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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: 421121 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01363

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee On Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. This child was vaccinated completely as per schedule. This child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421122 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, Inappropriate schedule of drug administration, Influenza
SMQs:, Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01364

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. The patient was partially vaccinated and did not complete vaccination schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421123 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, Inappropriate schedule of drug administration, Influenza
SMQs:, Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01333

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. The patient was partially vaccinated and did not complete vaccination schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421124 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01347

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421125 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01348

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421126 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01351

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421127 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01353

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421128 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01355

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421129 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01356

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. It was unknown if the patient was vaccinated completely as per schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421130 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01359

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. It was unknown if the patient was vaccinated completely as per schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 421131 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-28
Entered: 2011-04-15
   Days after submission:45
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, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US01360

Write-up: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. It was unknown if the patient was vaccinated completely as per schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.


VAERS ID: 432081 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-08-26
Entered: 2011-08-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
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: 2011029608

Write-up: This literature report with sparse information (initial receipt: 19-Aug-2011) concerns a male patient who died from Guillain-Barre syndrome after receiving influenza vaccination. Of note, the patient''s daughter experienced a serious adverse event after receiving influenza vaccine (WAVES 2011029570).


VAERS ID: 433733 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-09-02
Entered: 2011-09-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Malaise
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: The patient worked out and had been fit.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201108152

Write-up: Initial report was received 31 August 2011 from a consumer who was a co-worker of the patient. A female patient (age and date of birth not reported), who was fit and worked out, had received an injection of swine INFLUENZA VACCINE during the 1970s and right before Christmas, she became ill. The patient died two years later. According to the reporter, at first they thought it was GBS (Guillain-Barre Syndrome), but it was found to be "something else" (unknown by the reporter). Per the reporter, she had no additional information to provide regarding this event. The reporter further stated that the business where they worked had been bought and sold several times and had since gone out of business; therefore, there is no one to contact for follow-up. The reporter for this case is the same as for case numbers 2011-08149 and 2011-08150.


VAERS ID: 436542 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-09-30
Entered: 2011-10-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza, Influenza virus test positive
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: Neurologic disorder; Pulmonary disease; Chromosomal abnormality or genetic disorder; Congenital heart disease; Cardiac disease; Immunosuppressive condition; Obesity; Endocrine disorder; Mitochondrial disorder; Renal disease; Pregnant.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Group A streptococcus, positive; Staphylococcus aureus, positive; Streptococcus pneumoniae, positive
CDC Split Type: 2011029810

Write-up: This literature report (initial receipt 19-Sep-2011) concerns 17 children. This literature report summarises 115 cases of influenza-associated pediatric mortality reported to CDC (Centre for Disease Control and Prevention) that occurred from 01-Sep-2010 to 31-Aug-2011. A case was defined as a death from a clinically compatible illness confirmed to be influenza by a diagnostic test in a resident aged < 18 years, with no period of complete recovery between illness and death. Confirmatory influenza testing methods include commercial rapid diagnostic tests, viral culture, fluorescent antibody, enzyme immunoassay, reverse transcription-polymerase chain reaction and immunohistochemistry. Information about influenza vaccination was available for 74 children aged 6 months or greater; 17 received influenza vaccine in the appropriate number of doses at least 14 days before illness onset. Of 39 vaccine-eligible children with agency-defined high-risk medical conditions who had vaccination data available, 12 had been vaccinated according to 2010 agency recommendations. Among children who dies from influenza described in the report, 23% were vaccinated. 49% of the children who died had no known agency-defined high-risk medical conditions, 57 children were reported with medical conditions recognised by agency that placed them at increased risk for influenza-related complications and the medical history of two children was unknown. Of the 57 children with at least one agency-defined high-risk condition, 31 had a neurologic disorder, 17 had pulmonary disease, 14 had a chromosomal abnormality or genetic disorder, 11 had congenital heart disease or other cardiac disease, and 11 had asthma or reactive airway disease. Obesity was reported in two of the 57 children. Other types of agency-defined high risk conditions that were reported for children who died from influenza associated illness include immunosuppressive disorder (9 children), endocrine disorder (5 children), mitochondrial disorder (3 children), renal disease (2 children) and pregnancy (1 child). Of the 115 influenza-associated pediatric deaths reported, 72 occurred in males. The median age of patients was 6 years, and 53 cases were in children aged < 5 years. 71 of these cases were associated with influenza A virus infection; 30 cases were 2009 influenza A (H1N1), 21 cases were influenza A (H3N2) and 20 cases were influenza A viruses for which the subtype was not determined. The remaining 44 cases were associated with influenza B virus infections. Of 64 children who had specimens collected for bacterial culture from normally sterile sites (including 58 blood cultures), 25 had positive cultures; staphylococcus aureus was detected in nine patients (six with methicillin-resistant S. aureus, two with methicillin-sensitive S. aureus, and one with unknown sensitivity). streptococcus pneumoniae was detected in six patients, and Group A streptococcus was detected in three. The most frequent complications reported were radiographically confirmed pneumonia (62%), shock or sepsis (40%), and acute respiratory distress syndrome (34%). Encephalopathy or encephalitis was reported in 12 children (14%). Other complications included seizures (13%), hemorrhagic pneumonia/pneumonitis (6%), croup (5%), cardiomyopathy/myocarditis (4%) and bronchiolitis (2%). Of the 47 children who received antiviral therapy, three died in the emergency department and 44 died after being admitted to the hospital. All three children who died in the emergency department received oseltamivir. Of the children who died after being admitted to the hospital, 41 received oseltamivir only, two received oseltamivir and zanamivir and one received zanamivir only.


VAERS ID: 436704 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-09-30
Entered: 2011-10-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cardio-respiratory arrest, Convulsion, Death, Hypoxia, Hypoxic-ischaemic encephalopathy, Myelopathy, Nervous system disorder, Pyrexia, Spinal cord ischaemia, Status epilepticus
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had a history of recurrent CNS infections by unidentified agents (which were thought to have been viral), was developmentally delayed and microcephalic.
Allergies:
Diagnostic Lab Data: Post mortem examination disclosed acute hypoxic-ischemic encephalomyelopathy.
CDC Split Type: 201109245

Write-up: Initial case retrieved from the scientific literature on 22 September 2011.The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTAP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09246, -09247, -09248, -09249 and 2011-09250. A three-year-old female patient (who was one of triplets) and who had a history of developmental delay, microcephalic, and recurrent CNS infections by unidentified agents which were thought to have been viral, had received an INFLUENZA VACCINE (manufacturer unknown; lot number, route, site and date of administration not reported) when she was 3 years 9 months old. Two weeks later, she presented with CNS symptoms similar to those she had had unassociated with vaccination in the past, including fever. The day following hospitalization, she had a seizure which proceeded to status epilepticus and cardio-respiratory arrest. Respirator therapy was terminated on the following day. Postmortem examination disclosed acute hypoxic-ischemic encephalomyelopathy, noted to have been secondary to status epilepticus. Documents held by sender: None.


VAERS ID: 436735 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-10-03
Entered: 2011-10-04
   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 disseminated encephalomyelitis, Anaesthesia, Brain stem syndrome, C-reactive protein increased, CSF lymphocyte count increased, CSF monocyte count increased, CSF neutrophil count increased, CSF protein increased, CSF test abnormal, CSF white blood cell count increased, Central nervous system inflammation, Death, Dysarthria, Encephalopathy, Endotracheal intubation, Extensor plantar response, Fatigue, Headache, Hemiparesis, Hemiplegia, Hiccups, Hyperreflexia, Incontinence, Malaise, Muscle spasticity, Nausea, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Pleocytosis, Pneumonia, Quadriplegia, Respiratory failure, Rheumatoid factor negative, Spinal cord disorder, VIth nerve paralysis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Type 2 diabetes mellitus; dyslipidaemia; hypertension; hypothyroidism
Preexisting Conditions: Seronegative arthritis
Allergies:
Diagnostic Lab Data: C-reactive protein increased, high, 37.4mg/l; CSF lymphocyte count, significant, 29%; CSF monocyte count, significant, 15%; CSF neutrophil count, significant, 56%; CSF protein, significant, 911 mg/l; CSF test abnormal, significant demonstrated lymphocytic pleocytosis, abnormal; CSF white blood cell count, 208/micro L; Nuclear magnetic resonance imaging, brain, significant, Magnetic resonance imaging (MRI) of the brain and the spine demonstrated a long segment of T2 hyperintensy 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. Abnormal
CDC Split Type: PHHY2011CA86216

Write-up: Case number PHHY2011CA86216 is an initial literature report received on 27 Sep 2011. Authors presented a case of acute disseminated encephalomyelitis (ADME) following influenza vaccination. This case refers to a 75-year-old female patient. 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. She was vaccinated with an inactivated seasonal influenza vaccine (manufacturer and batch number: Unknown) on an undetermined date in 2008. She presented with a 20 day history of headache, malaise, fatigue, intractable hiccups, nausea and vomiting in Nov 2008. It was reported that the symptoms began evolving 2 days following receipt of vaccination. She 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. Magnetic resonance imaging 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 presented 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 presented 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 demonstrated lymphocytic pleocytosis (white blood cell count of 208/micro L), 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 pathology was negative for malignant cells. Her clinical and radiologic findings fulfilled published criteria for ADEM according to the Brighton Collaboration Encephalitis Working Group. Despite treatment with broad-spectrum antibiotics, acyclovir, methylprednisolone and plasma exchange therapy (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. Authors stated that seeing as the patient passed away 70 days PI and did not attain the minimum 3 months follow-up duration required to document a monophasic pattern of illness and fulfill a level 1 of diagnostic certainty, her case meets a level 2 of diagnostic certainty for ADEM. Although CSF findings are not included in the abovementioned diagnostic definition of ADEM, the CSF pleocytosis and elevated protein in this patient are useful indicators of central nervous system inflammation. Authors also stated that brainstem dysfunction may serve as a poor prognostic indicator. When assessing post-vaccination adverse events it is always difficult to separate causality from a temporal coincidence, however, in accordance with the World Health Organization''s causality assessment criteria it is ''very likely'' that in this case disease was caused by the administration of vaccine.


VAERS ID: 438050 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-10-12
Entered: 2011-10-13
   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: Autopsy, Cardio-respiratory arrest, Convulsion, Death, Hypoxic-ischaemic encephalopathy, Pyrexia, Respiratory therapy, Similar reaction on previous exposure to drug, Status epilepticus
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), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), 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:
Other Medications: No other medications
Current Illness: Central nervous system infection; microcephaly
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2011US89577

Write-up: Case number PHHY2011US89577 is an initial literature report received on 06 Oct 2011: The authors analyzed clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program. This report refers to a female child. She was one of the triplet and her medical history included recurrent CNS infections by unidentified agents, but which were thought to have been viral. She was developmentally delayed and microcephalic. At the age of 3 years and 9 months, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on an unspecified date. Two weeks later, she presented with CNS symptoms similar to those she had unassociated with vaccination in the past, including fever. The day following hospitalization, she had a seizure which proceeded to status epilepticus and cardio-respiratory arrest. Respiratory therapy was terminated on the following day. Postmortem examination disclosed acute hypoxic-ischemic encephalomyelopathy. The authors concluded that provided evidences were not supportive of direct relationship between a given vaccine and a specific CNS complication. Pathogenesis of majority of the cases was apparent and not a complication of vaccination.


VAERS ID: 443774 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-11-21
Entered: 2011-11-21
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 prolonged, Ageusia, Asthenia, Biopsy bone marrow abnormal, Biopsy skin abnormal, Blood cortisol normal, Blood electrolytes normal, Blood fibrinogen decreased, Blood follicle stimulating hormone decreased, Blood gonadotrophin decreased, Blood luteinising hormone decreased, Blood osmolarity increased, Blood prolactin normal, Blood sodium increased, Blood thyroid stimulating hormone, Blood triglycerides normal, Cachexia, Colonic polyp, Colonoscopy abnormal, Computerised tomogram abdomen abnormal, Culture urine negative, Cytomegalovirus test negative, Death, Decreased appetite, Diabetes insipidus, Disseminated intravascular coagulation, Dysgeusia, Electrophoresis protein abnormal, Endoscopy gastrointestinal, Endoscopy gastrointestinal normal, Epstein-Barr virus antibody positive, Fatigue, Gastrointestinal haemorrhage, Haemoglobin decreased, Hepatosplenomegaly, Herpes simplex serology negative, High density lipoprotein increased, Histiocytosis haematophagic, Human herpes virus 6 serology negative, Hypergammaglobulinaemia, Hyperplasia, Hypothalamo-pituitary disorder, Influenza like illness, International normalised ratio increased, Iron deficiency anaemia, Laboratory test normal, Leukocytosis, Liver function test normal, Low density lipoprotein decreased, Lymphocyte percentage decreased, Macrophage activation, Marrow hyperplasia, Mean cell volume decreased, Monocyte percentage increased, Multi-organ failure, Neutrophil count normal, Nitrite urine absent, Nodule, Normochromic normocytic anaemia, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Parvovirus B19 test positive, Periarthritis, Platelet count decreased, Pollakiuria, Polydipsia, Polyuria, Protein total decreased, Pyrexia, Rash, Rash maculo-papular, Red blood cell sedimentation rate increased, Red cell distribution width increased, Reticulocyte percentage normal, Sepsis, Serum ferritin increased, Simplex virus test positive, Thirst, Thrombocytopenia, Thyroid function test normal, Thyroxine free normal, Transfusion, Urinary tract infection, Urine leukocyte esterase positive, Urine osmolarity decreased, Urine output increased, Urine sodium decreased, Weight decreased, White blood cell count increased, White blood cells urine positive
SMQs:, Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Dyslipidaemia (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific inflammation (broad), Hyponatraemia/SIADH (broad), Ischaemic colitis (broad), Skin tumours of unspecified malignancy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Malignant lymphomas (broad), Arthritis (narrow), Myelodysplastic syndrome (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Dehydration (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: vitamin D; lorazepam
Current Illness: hypertension
Preexisting Conditions: Risedronate sodium for osteoporosis; Alendronate sodium; Two infusions of zoledronic acid, her last one in Oct 2009; Gastric ulcer; Transient ischaemic attack; Computed tomography of the brain without contrast in Jul 2009 revealed small vessel ischemia
Allergies:
Diagnostic Lab Data: Biopsy bone marrow, significant, revealed a markedly hypercellular marrow (near 100% cellularity) with trilinear hyperplasia; biopsy skin, significant, the pathologic findings showed histiocyte collections within the epidermis and papillary dermis that stained positive for CD43; blood cortisol, 22,3 g/dL, high; blood follicle stimulating hormone, decreased low, 44 pg/mL; blood follicle stimulating hormone, decreased, 24.2 mlU/mL; blood luteinising hormone decreased, low, 11.2 mlU/mL; colonoscopy, significant, three non-bleeding polyps; computerised tomogram, significant, computed tomography of the abdomen and pelvis showed hepatosplenomegaly with heterogeneous enhancement suggestive of an infiltrative process; Epstein-Barr virus antibody positive, positive, IgG antibodies to Epstein-Barr virus (EBV) were also found at a low titer in our patient (EBV viral capsid antigen, 1:80; EBV early antigen, 1:20; and Epstein-Barr nuclear antigen, 1:10); haemoglobin, low, 9.1 g/dl; international normalised ratio, high, 1.39; nuclear magnetic resonance imaging, significant, magnetic resonance imaging (MRI) of the pituitary revealed a 4-mm nodular lesion within the left lobe of the pituitary gland, consistent with a possible pituitary micro adenoma; platelet count, significant, 134 x 103/?L; protein total decreased, low, 6.5 g/dl; red blood cell sedimentation rate, significant, 42 mm/hour; simplex virus test positive, positive; urine leukocyte esterase, 3+; urine output, 3990 ml; urine output, 2550 ml; white blood cell count, high, 20, 000/?L; white blood cells urine positive, high, 31
CDC Split Type: PHHY2011US100194

Write-up: Case number PHHY2011US100194 is an initial literature report received on 14 Nov 2011: The authors reported the first case of central diabetes insipidus associated with hemophagocytic lympho-histocytosis following vaccination with H1N1 vaccine. This report refers to a 75-year-old female patient. Her past medical history was significant for osteoporosis treated with risedronate for one year, then alendronate for one year, after which she received two infusions of zoledronic acid, her last one in Oct 2009. She had a history of gastric ulcer at age 60, a possible transient ischemic attack in Jul 2009, and hypertension. Computed tomography of the brain without contrast in Jul 2009 revealed small vessel ischemia. Her only medications were vitamin D, 50,000 IU once a month, and lorazepam, 0.5 mg, for anxiety. She was vaccinated with H1N1 vaccine (batch number and manufacturer: unknown) on an undetermined date in 2010. One month after vaccination she presented with flu-like illness in Mar 2010 and was treated with oseltamivir phosphate. However, within several days of developing this flu-like illness, she began to have polyuria associated with polydipsia and loss of appetite. A urine culture was negative. She was asked to record her urinary volume over a 24-hour period. On two successive days, her 24-hour urinary volumes were 3, 990 mL and 2, 550 mL respectively. An overnight dehydration test was performed, and her morning urine sodium concentration was 22 mEq/L, urine osmolarity was 145 mOsm/kg, serum sodium concentration was 147 mEq/L, and serum osmolarity was 314 mOsm/kg. She continued to complain of generalized weakness, loss of appetite, loss of taste for salt, excessive thirst, and frequent urination. She was found to have iron-deficiency anemia with an elevated erythrocyte sedimentation rate of 42 mm/hour (normal, less than 20 mm/hour). Her fasting serum gastric level was 44 pg/mL (normal, less than 200 pg/mL), serum prolactin level was 16.7 ng/mL (reference range, 1.9 to 25 ng/mL), and serum protein electrophoresis revealed a polyclonal gamma increase. Her follicle-stimulating hormone level was 24.2 mlU/mL (normal postmenopausal, more than 25) and luteinizing hormone level was 11.2 mlU/mL (normal postmenopausal , more than 20 mlU/mL). Thyroid and liver function tests were normal. Magnetic resonance imaging (MRI) of the pituitary revealed a 4-mm nodular lesion within the left lobe of the pituitary gland, consistent with a possible pituitary micro adenoma. In May 2010, she was started on intranasal 1-deamino-8-D-arginine vasopressin (DDAP) supplementation, one puff at bedtime, with marked improvement of her polyuria. A few days later she developed gastrointestinal bleeding and was hospitalized. She was found to have three non bleeding polyps on colonoscopy and had a negative capsule endoscopy. Her polyuria remained improved on DDAVP. In Aug 2010, she was readmitted with intermittent daily fevers that reached 39.5 degree Celsius, a white blood cell (WBC) count of 20, 000/L (reference range, 3, 500 to 9,000/L) with 65% neutrophils, 15% lymphocytes, 17% monocytes, and 3% band forms indicating leukocytosis, and a urinary tract infection (indicated by the presence of 3+ leukocyte esterase, no nitrites, and 31 WBCs on urinalysis). She had progressive fatigue and anorexia and had lost 3.6 kg in the past few months (from 49.5 to 45.9 kg). She appeared cachectic on examination. She was not orthostatic, acromegalic, or Cushingoid and demonstrated full visual fields. Her thyroid was not enlarged. There was a diffuse, maculopapular rash confluent on her torso and abdomen and palpable hepatosplenomegaly. Aside from leukocytosis, admission laboratory results were also notable for normocytic anemia (hemoglobin, 9.1 g/dL (reference range, 12 to 15.8 g/dL); mean corpuscular volume, 79.5 fl (reference range, 79 to 93 fL); red blood cell distribution width, 15.1% (normal, less than 14.5%), with absence of reticulocyte response (1.5%), mild thrombocytopenia (platelet count was 134 x 103/uL, reference rang 165 to 415 x103/uL), an elevated international normalized ratio of 1.39 (reference range, 0.86 to 1.16), and a partial thromboplastin time of 43.4 seconds (reference range, 24.4 to 37.9 seconds). Electrolytes and hepatic function tests were essentially normal with the exception of mildly reduced total protein 6.5 g/dL (reference range, 6.7 to 8.6 g/dL). Results of a fasting lipid panel were as follows: high-density lipoprotein, 3 mg/dL; low-density lipoprotein, 46 mg/dL; and triglycerides, 118 mg/dL. Assessment of the hypothalamic-pituitary-adrenal axis demonstrated a robust 8 am serum cortisol of 22.3 ug/dL (reference range, 5 to 21 ug/dL), normal thyroid function tests thyrotropin, as 2.43 mlU/L (reference range, 0.32 to 4.05 mlU/L) and free thyroxine as 1.09 ng/dL (reference range, 0.7 to 1.24 ng/dL), mildly suppressed gonadotropins for a postmenopausal woman (follicle-stimulating hormone, 10.4 mlU/mL and luteinizing hormone, 6.9 m;U/mL), and a normal prolactin level (22.5 ng/mL). Two MRIs of the brain with focused imaging of the sella region were performed at 1.5 Tesia before and after administration of contrast material. The overall appearance of the brain was unremarkable for a 75-year-old woman with history of mild hypertension. Specifically, no parenchymal brain mass and no abnormal parenchymal or meningeal enhance, enhancement affected the cerebrum, brainstem, or cerebellum. The ventricular size was normal. There was focal thickening of the pituitary infundibulum extending to its insertion into the hypothalamus. This finding was most obvious as plaque like contrast enhancement surrounding the infundibulum. The pituitary gland was of normal size. The posterior pituitary signal intensity was a bit lower and more heterogeneous than normal. The pituitary gland enhanced somewhat heterogeneously post contrast administration, but there was no clear evidence of microadenoma. The sella and the remainder of the hypothalamus were entirely unremarkable. These findings were similar on both MRI exams performed. The patient remained febrile despite the escalation of her antibiotics to treatment with piperacillin and tazobactam. Polydipsia and polyuria remained well-controlled on DDAVP. Dermatology was consulted and performed a skin biopsy; the pathologic findings showed histiocyte collections within the epidermis and papillary dermis that stained positive for CD43. Computed tomography of the abdomen and pelvis showed hepatosplenomegaly with heterogeneous enhancement suggestive of an infiltrative process. Her leukocytosis progressively increased to a WBC count of 93, 800/uL with worsening anemia (hemoglobin, 6.1 g/dL) and thrombocytopenia (platelet count, 12 x 103/uL) requiring transfusions. Oncology was consulted and performed a bone marrow biopsy, which revealed a markedly hypercellular marrow (nearly 100% cellularity) with trilinear hyperplasia. CD68 (PGM1) immunostaining demonstrated florid histiocytosis and hemophagocytosis in the marrow - pathognomonic of hemophagocytic lymphohistiocytosis (HLH) without evidence of malignancy. CD1 a staining for Langerhans cell histiocytosis (LCH) was negative. Herpes simplex virus 1 DNA was detected at a low titer in her serum; herpes simplex virus 2, human herpes virus 6, and cytomegalovirus DNA were not detected. IgG antibodies to parvovirus B19 were present, but there was no evidence of current infection. IgG antibodies to Epstein-Barr virus (EBV) were also found at a low titer in our patient (EBV viral capsid antigen, 1:80; EBV early antigen, 1:20 and Epstein-Barr nuclear antigen, 1:10), as was a very low copy number of EBV DNA by quantitative polymerase chain reaction (100 DNA copies/mL, assay range, 100 10 1 x 10^10 copies/mL). She had an elevated ferritin level. She was started on etoposide and dexamethasone for treatment of HLH, but soon died of multiorgan failure die to sepsis and disseminated intravascular coagulation despite cryoprecipitate and blood product support. Even though the patient had normal fibrinogen levels previously, she had low level (96mg/dL) on the morning of her death. The patient''s family declined a postmortem examination. The authors concluded that the patient demonstrated no evidence of either autoimmunity or malignancy despite her marked leukocytosis, EBV was commonly reported to be associated with secondary HLH, but most herpes viruses had been reported to cause this rare syndrome so it was possible that either EBV or herpes simplex virus 1 might have bee the trigger for macrophage activation in this patient. It was of interest, however, that this patient developed a flulike illness 1 month after receiving the H1N1 vaccine. The authors further commented that HLH should be added to the differential diagnosis in a patient with new onset central diabetes insipidus, especially after febrile illness. Whether this patient''s illness was related to the vaccination or was purely coincidental was speculative, but worth noting.


VAERS ID: 444090 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2011-12-01
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: 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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201111326

Write-up: Initial report received on 17 November 2011 via search of the literature. This case involved reports received through 01 March 2010 by the CDC of pregnant women who were vaccinated with the 2009 H1N1 vaccine (trade name, manufacturer name and lot number not reported) during 01 October 2009 through 28 February 2010. Some of these patients (31/294 patients) may have also received a dose of seasonal INFLUENZA vaccine (trade name, manufacturer name and lot number not reported). Non-country reports were excluded. Include in the reports were AEs in neonates of the report indicated their mother had received 2009 H1N1 vaccine during pregnancy. One of those patients was born with congenital anomaly and has been captured in case number 2011-11325. Information regarding that patient''s mother has been captured in case number 2011-11324. Regarding this case: Characteristics of the reports (which included all 294 patients that were vaccinated) were received by the CDC of pregnant women vaccinated 01 October 2009 through 28 February 2010: 60/294 reports were serious; 2/294 involved deaths (1 patient died from ruptured aortic aneurysm, and one patient died from hemorrhagic shock. In both cases the neonates were born alive); median maternal age of patients was 30 years of age (age range 15.0-46.0 years); median onset interval for onset of adverse and serious adverse events was 2 days (range 0-84.0 days); Median gestational age (in weeks) at time of vaccinations was 13 weeks (range 3.0-39.0 weeks) with 133/247 patients in the first trimester of pregnancy, 67/247 in the second trimester and 42.247 in the third trimester. Adverse events that had been reported after vaccinations included: Pregnancy-specific outcomes: SAB (121; 41.2%); Stillbirth (19; 6.5%); preterm delivery (7; 2.4 %); threatened abortion (4; 1.4%); preterm labor (3; 1.0%); maternal death (2; 0.7%); preeclampsia (2; 0.7%); intrauterine growth restriction (2; 0.7%); fetal hydronephrosis (1; 0.3%); fetal tachycardia (1; 0.3%); cleft lip (1:0.3%); neonatal intraparenchymal hemorrhage (1; 0.3%); and intrauterine fetal death (1; 0.3%). Non-pregnancy-specific outcomes included allergic reactions other than anaphylaxis (36; 12.2 %); general or constitutional symptoms (28; 9.5%); local reactions (10; 3.4%); paresthesias (8; 2.7%); Bell''s Palsy (5; 1.7%); syncope (5; 1.7%); dizziness (5; 1.7%); hypoesthesia (3; 1.0%); headache (3; 1.0%); anaphylaxis (1;0.3%); and other (25; 8.5%, which included anxiety, arthralgia, asthenia, arthritis, blurred vision, chest pain, chronic bronchitis, cough, diarrhea, dyspnea, eye swelling, influenza, influenza-like illness, lip injury, nail bleeding, panic attack, shingles, wheezing, tachycardia, tremors, unusual taste, upper respiratory infection, wheezing). Risk factors for the SABs (which were 95) and stillbirths (which were 18) included advanced maternal age, smoking, history of intrauterine fetal death, hypothyroidism, diabetes mellitus, urinary tract infection, alcohol or drug use, obesity, and "other" (which included chlamydia infection and complicated pregnancy, congenital malformations in past pregnancies, uncontrolled diabetes, chronic hypertension, positive Down Syndrome screening, k chronic hypertension, and macrocytic hyperchromic anemia). Recovery status was not reported for any of the patients. The following is verbatim from the published summary of the article regarding all patients: "Background and Objective: In April 2009, H1N1 virus infection( 2009 H1N1) was identified. The Advisory Committee on Immunization Practices recommended that pregnant women (in any trimester) be included as an initial target group for 2009 H1N1 vaccination. Monitoring adverse events (AEs) following 2009 H1N1 vaccine administration in pregnant woman was a priority for the Centers for Disease Control and Prevention (CDC) in collaboration with the Food and Drug Administration (FDA). Raid surveillance was conducted for adverse events reported to Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received H1N1 vaccines to assess for potential vaccine safety problems. Materials and Methods: The VAERS, established in 1990, is jointly administered by the CDC and FDA. VAERS generally cannot assess whether a vaccination caused an AE but can identify possible vaccines safety problems for further investigation. Reports are classified as serious, based on the Code of Federal Regulations, if they result in death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, or congenital anomaly. As part of the federal response to monitor the safety of 2009 H1N1 vaccine, VAERS was enhanced in several ways. VAERS reports received through March 1, 2010, on pregnant women vaccinated with 2009 H1N1 vaccine from Oct.1, 2009, through Feb. 28, 2010 were analyzed. Included were reports of AEs in neonates if the report indicated that their mothers had received the 2009 H1N1 vaccine during pregnancy. All VAERS reports for pregnant cases were manually reviewed. Medical records were requested for all reports that suggested the vaccinee was pregnant at the time of receipt of the 2009 H1N1 vaccine or that concerned infants born to mothers who had received 2009 H1N1 vaccine during pregnancy. Reporting rated of AEs in pregnant women were calculated by dividing the number of AEs by the estimated number of inactivated 2009 H1N1 vaccines doses administered to pregnant women during the time period were covered in this review. RESULTS: From Oct. 1, 2009, through Feb.28, 2010, VAERS received 294 reports; 288 followed inactivated and 6 followed live vaccines. Sixty reports (20.4%) were coded as serious, including 2 maternal deaths. Serious reports corresponded to 59 pregnant women who were hospitalized for any reason and 1 to an infant born with a congenital anomaly. The 2009 H1N1 vaccine was reported as administered mostly during the first (133; 53.9%) or second trimester of pregnancy (67; 27.1%). The most frequent pregnancy-specific AE reported following 2009 H1N1 vaccine administration was spontaneous abortion (SAB) in 121 women (41.2% of reports), followed by stillbirth in 19 women (6.5% of reports). Ninety-five SABs (78.5%) and 18 stillbirths (94.7%) were verified by review of medical records. Five fetal adverse outcomes were reported. Risk factors for SAB were identified in 47 of the 95 verified reports (49.5%). The most common risk factor was maternal age 35 years or older in 25 (26.3%) reports. Of 18 stillbirths with verified diagnosis, 13 (72.2%) had at least 1 maternal risk factor for stillbirth or a pathologic finding that may have contributed to the fetal demise. The overall reporting rate of AEs to VAERS in pregnant women after inactivated 2009 H1N1 vaccine was 118.2 reports per 1 million pregnant women vaccinated. The reporting rates for SABs and stillbirths were 49.2 and 7.8 reports, respectively, per 1 million pregnant women vaccinated. Table of adverse events (presented in the article) were based on main diagnosis following medical chart review. The events included: Pregnancy-specific outcome of SAB (121; 41.2%); stillbirth (19; 6.5%); preterm delivery (7; 2.4%); threatened abortion (4; 1.4%); preterm labor (3; 1.0%); maternal death (2; 0.7%); preeclampsia (2; 0.7%); intrauterine growth restriction (2; 0.7%); fetal hydronephrosis (1; 0.3%); fetal tachycardia (1; 0.3%); cleft lip (1; 0.3%); neonatal intraparenchymal hemorrhage (1; 0.3%); and intrauterine fetal death (1; 0.3%). Non-pregnancy-specific outcomes included allergic reactions other than anaphylaxis (36; 12.2%); general or constitutional symptoms (28; 9.5%); local reactions (10; 3.4%); paresthesias (8; 2.7%); Bell''s Palsy (5; 1.7%); syncope (5; 1.7%); dizziness (5; 1.7%); hypoesthesia (3; 1.0%); headache (3; 1.0%); anaphylaxis (1; 0.3%); and other (25; 8.5%, Includes anxiety, arthralgia, asthenia, asthma, arthritis, blurred vision, chest pain, chronic bronchitis, cough, diarrhea, dyspnea, eye swelling, influenza, influenza-like illness, lip injury, nail bleeding, panic attack, shingles, sneezing, tachycardia, tremors, unusual taste, upper respiratory infection, wheezing). Comment: From October 2009 through February 2010, approximately 3% of reports to VAERS after 2009 H1N1 vaccine were of pregnant women who experienced at least 1 AE after vaccination. Among these 294 reports of AEs, no unusual patterns of adverse maternal or fetal outcomes were observed. The most common pregnancy-specific AE reported was SAB. In the review of medical records, more than an third of women who experienced a SAB had at least 1 risk factor, the most common being advance maternal age. The second most common pregnancy specific AE was stillbirth. Careful review of medical records revealed that 72% of those women had at least 1 risk factor or a pathologic finding in the fetus or placenta, suggesting factors other than vaccination that may have contributed to the fetal demise. SAB is a relatively frequent event in pregnancy, with a rate as high as 22.4% in women aged 34 years or older and 10.4% in women younger than 25 years. Stillbirths occur at a background rate of 0.4% of all pregnancies or 6.22 per 1000 live births and fetal deaths. There is underreporting to VAERS in general and the proportion of AEs following immunization among pregnant women that are reported to VAERS is unknown. Nonetheless, the reporting rates to VAERS for SABs and stillbirths after H1N1 vaccines was several orders of magnitude lower than the expected rates of fetal losses in the general population of pregnant women during a time of heightened awareness about vaccine safety. The VAERS data provided no indication that the occurrence of SAB and stillbirths following INFLUENZA vaccination was higher than in the general population. Other AEs observed in pregnant women were mostly nonserious and were similar to those reported in a preliminary review of the safety of 2009 H1N1 vaccines among the general population. VAERS is a passive surveillance system that may be prone to biased reporting (over-or underreporting) and inconsistency in the quality and completeness of reports. VAERS generally cannot determine whether a vaccine caused an AE. Stimulated reporting can occur following publicity around a potential AE. One important limitation of VAERS is that it collects data only on vaccinated individuals who have experienced an AE. The total vaccinated population is not known with certainty and therefore incidence rates of AE cannot be directly calculated. Review of VAERS reports following 2009 H1N1 vaccination had provided a comprehensive and rapid assessment of the safety of inactivated 2009 H1N1 vaccine among pregnant women during a period when INFLUENZA vaccine coverage during pregnancy was at its highest recorded levels. Clinical Implications: 1) No unusual patterns of adverse maternal or fetal outcomes were observed in pregnant women who received influenza A 2009 monovalent vaccines and who reported to the Vaccine Adverse Event Reporting System (VAERS). 2) The reporting rates of spontaneous abortion and stillbirth were markedly lower than the expected number of fetal losses in the general population of pregnant women, probably because of underreporting in VAERS. 3) VAERS generally cannot assess whether a vaccination caused an adverse event but can identify possible vaccine safety problems for further investigation. 4) Findings in passive surveillance systems such as VAERS need to be interpreted with caution, given their inherent limitations, such as over-underreporting, biased reporting, and inconsistency in quality and completeness of reports." Documents held by sender: None.


VAERS ID: 445896 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
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: 2011030535

Write-up: This literature report (initial receipt 10-Dec-2011) concerns patients who were vaccinated with 2009-2010 seasonal influenza or 2009-H1N1 inactivated or live attenuated (WAVES 2011030534) vaccines from 01-Jul-2009 through 31-Jan-2010 and reported to VAERS (Vaccine Adverse Event Reporting System). There were 48 deaths with reported cause of death category after record review of cardiac, infectious, multiple systems, neurologic, motor vehicle accident, pregnancy complication, respiratory and unknown. Results of clinical review of death, cardiovascular conditions were the most common reported cause of death (22 reports). Underlying medical conditions and risk factors for cardiovascular disease, were present among 94% (45/48) of the patients who died. In some cases the cause of death was clearly unrelated to vaccination (e.g. meningococcal sepsis, ruptured aortic aneurysm). Molecular testing did not identify vaccine strain virus in lung tissue for the three individuals tested and who received live, attenuated 2009-H1N1 vaccine. No deaths from anaphylaxis were reported. There were 8 death reports where the patient also received seasonal influenza and H1N1 vaccination on the same day. There were 99 verified reports of GBS (Guillain-barre syndrome), 24 had received seasonal influenza vaccine on the same day or within 30 days of the 2009-H1N1 vaccine (live attenuated or inactivated). The author also verified 117 reports of anaphylaxis, 15 had received seasonal influenza and H1N1 vaccine (live attenuated or inactivated) on the same day. The event outcome was not reported. The adverse event profile after 2009-H1N1 vaccine in VAERS was consistent with that of seasonal influenza vaccines.


VAERS ID: 446200 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-12-22
Entered: 2011-12-23
   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: 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: Risk factor(s): Advanced maternal age, Smoking, History of Intra-uterine fetal death, Hypothyroidism, Diabetes Mellitus, Urinary tract infection, Alcohol use, Drug use, Obesity, Type 1 diabetes, Type II diabetes, History of gestational diabetes, Chlamydia infection and complicated pregnancy, Congenital malformations in past pregnancies, Uncontrolled diabetes, Chronic hypertension, positive Down''s Syndrome screening, macrocytic hyperchromic anaemia. Pregnant: Yes. Result: STILL BIRTH.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011030537

Write-up: This literature report (initial receipt 14-Dec-2011) concerns VAERS (Vaccine Adverse Event Reporting System) reports received through 01-Mar-2010, on pregnant women who were vaccinated with the H1N1 during 01-Oct-2009 through 28-Feb-2010. Foreign reports were excluded. The author included reports of AEs (adverse events) in neonates if the report indicated that their mothers had received H1N1 during pregnancy. Risk factors for spontaneous abortions included the following; advanced maternal age equal or $g35 years (25 patients), smoking (7 patients), history of intrauterine fetal death (4 patients), hypothyroidism (4 patients), diabetes mellitus type 1 (1 patient), diabetes mellitus type II (1 patient), history of gestational diabetes (1 patient), alcohol or drug use (2 patients), obesity (1 patient) and other (1 patient). ''Other'' risk factors for spontaneous abortions were defined as the following; chlamydia infection with complicated pregnancy. Risk factors for stillbirth included the following; advanced maternal age equal or $g35 years (5 patients), smoking (3 patients), history of intrauterine fetal death (2 patients), diabetes mellitus type 1 (1 patient), history of gestational diabetes (1 patient), alcohol or drug use (4 patients), obesity (3 patients) and other (7 patient). ''Other'' risk factors for stillbirth included the following; congenital malformations in past pregnancies, uncontrolled diabetes, chronic hypertension, positive Down Syndrome screening and macrocytic hyperchromic anaemia. From 01-Oct-2009 through 28-Feb-2010, VAERS received a total of 10,186 reports after H1N1 vaccination; 422 of these reports involved pregnant women. The author excluded 128 pregnancy reports in which no AE was reported after the administration of inactivated or live H1N1. These pregnant women are being followed up prospectively as part of a separate CDC (Centres for Disease Control and Prevention) study that seeks to assess delivery and infant outcomes. Of the remaining 294 reports, 288 followed inactivated and 6 followed live vaccines. Median maternal age was 30 years (range 15 - 46 years). Median onset interval (adverse event onset date and vaccination date) was 2 days (range 0 - 84 days). Median gestational age at time of vaccination was 13 weeks (range 3 - 39 weeks). The H1N1 was reported as administered mostly during the first (133; 53.8%) and second trimester of pregnancy (67; 27.1%). In 31 reports (10.5%), the H1N1 was administered on the same date as the seasonal influenza vaccine (WAVES 2011030539). Sixty reports (20.4%) were coded as serious, including 2 maternal deaths. Serious reports corresponded to 59 pregnant women who were hospitalized for any reason and 1 to an infant born with a congenital anomaly. The most frequent pregnancy-specific AE reported following H1N1 administration was SAB (spontaneous abortion) in 121 women (41.2% of reports), followed by stillbirth in 19 women (6.5% of reports), preterm delivery of 7 women (one case of preterm delivery where the infant of one mother died approximately 1 month after delivery), threatened abortion in 4 women, preterm labor in 3 women, maternal death in 2 women, preeclampsia in 2 women, intrauterine growth restriction in 2 women, fetal hydronephrosis in 1 woman, fetal tachycardia in 1 woman, cleft lip in 1 woman, neonatal intraparenchymal hemorrhage in 1 woman and intrauterine fetal death in 1 woman. Most SAB reports (n = 62) were received in Nov-2009 but reporting rapidly declined thereafter. All stillbirths were reported during Oct-2009 and Nov-2009 with 10 and 9 reports, respectively. In 42.4% of the SAB reports, the onset interval from the day of vaccination to onset of AE was 0-3 days (61 reports with onset of 0-6 days). In 47.4% of stillbirth reports, the onset interval was 0-6 days. The author did not observe any clustering of SAB or stillbirth cases by geographic location or lot number. Ninety-five SABs (78.5%) and 18 stillbirths (94.7%) were verified by review of medical records. Five fetal adverse outcomes were reported: 2 cases of intrauterine growth restriction and 1 case each of hydronephrosis, tachycardia, and cleft lip. The maternal deaths included 1 patient who experienced hemorrhagic shock because of uterine atony following a cesarean section and 1 patient who experienced a ruptured aortic aneurysm, which resulted in cardiac tamponade and subsequent death. A mild fetal hydronephrosis was detected in the patient during an ultrasound exam at 36 weeks'' gestation. However a postnatal ultrasound examination of the infant performed on day 2 of life failed to confirm the presence of hydronephrosis. Cause of death was not reported. Only 1 congenital anomaly was reported to VAERS: a cleft lip in an infant born to a 23 year old woman who was vaccinated at 19 weeks'' gestation. The cleft lip was first detected during a prenatal ultrasound examination at 22 weeks'' gestation. Cause of death was not reported. Because cleft lip was embryologically determined during the first trimester of pregnancy, it is implausible to consider vaccination at 19 weeks'' gestation as a possible causative agent. The most common non pregnancy specific AEs were non anaphylactic allergic reactions (36), constitutional symptoms (28), and local reactions (10). Two hundred thirty-five of the total reports (79.9%) did not require hospitalization. Five cases of Bells'' palsy and 1 case of anaphylaxis (meeting Brighton Collaboration case definition) were reported. No cases of Guillain-Barre syndrome were identified. There were 8 cases of paraesthesia''s, 5 cases each of syncope and dizziness, 3 cases each of hypoesthesia and headache and 25 cases of ''other'' Other events included anxiety, arthralgia, asthenia, asthma, arthritis, blurred vision, chest pain, chronic bronchitis, cough, diarrhoea, dyspnoea, eye swelling, influenza, influenza-like illness, lip injury, nail bleeding, panic attack, shingles, sneezing, tachycardia, tremors, unusual taste, upper respiratory tract and wheezing. One hundred twenty-one cases of SAB after H1N1 vaccination were reported to VAERS (120 after inactivated and 1 after live vaccine), of which 95 were verified. Medical records were not received for 16 reports, and in 10 reports, the available records were not sufficient to confirm the initial diagnosis of SAB. Risk factors for SAB were identified in 47 (49.5%) of the 95 verified reports. Thirty-six women had only 1 risk factor for SAB. The most common risk factor was advanced maternal age (defined as age $g or = 35 years) in 25 reports (26.3%). Nineteen stillbirths were reported to VAERS. Of 18 with verified diagnosis, 13 (72.2%) had at least 1 maternal risk factor for stillbirth (eg, obesity) or a pathological finding that may have contributed to the fetal demise. Fourteen of 18 reports had pathology reports. Pathological/placental or other findings were present in 13 of the 14 reports and included chorioamnionitis in 7 reports and 2 reports each of tight nuchal cord, fetal-maternal hemorrhage, and fetal growth restriction. Of note, the 6 adverse event cases involving live H1N1 included 1 case of spontaneous abortion, 2 cases of general/constitutional symptoms, 1 case each of dizziness, headache, and ''other''. The author estimated that during Oct-2009 through Feb-2010, 2,437,113 (95% confidence interval, 1,865,373-3,008,853) pregnant women were vaccinated with H1N1. The overall reporting rate of AEs to VAERS in pregnant women after H1N1 was 118.2 reports per 1 million pregnant women vaccinated. The reporting rates for SABs and stillbirths were 49.2 and 7.8 reports per 1 million pregnant women vaccinated, respectively. The event outcome was not reported. Reporter comments: Review of reports of VAERS following H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes.


VAERS ID: 446226 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-12-22
Entered: 2011-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / UNK UN / UN
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Risk factor(s): Advanced maternal age, Obesity, Chlamydia infection and complicated pregnancy, Congenital malformations in past pregnancies, Uncontrolled diabetes, Chronic hypertension, positive Down''s Syndrome screening, macrocytic hyperchromic anaemia, smoking, history of intrauterine fetal death, Alcohol use, Drug use, Diabetes mellitus type 1, Diabetes mellitus type II, Gestational diabetes, Urinary tract infection, Diabetes mellitus, Hypothyroidism; Pregnant: Yes; Result: STILL BIRTH
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2011030539

Write-up: This literature report (initial receipt 14-Dec-2011) concerns VAERS (Vaccine Adverse Event Reporting System) reports received through 01-Mar-2010, on pregnant women who were vaccinated with the seasonal influenza vaccine on the same date as the H1N1 during 01-Oct-2009 through 28-Feb-2010. Foreign reports were excluded. Risk factors for spontaneous abortions included the following; advanced maternal age equal or $g35 years (25 patients), smoking (7 patients), history of intrauterine fetal death (4 patients), hypothyroidism (4 patients), diabetes mellitus type 1 (1 patient), diabetes mellitus type II (1 patient), history of gestational diabetes (1 patient), alcohol or drug use (2 patients), obesity (1 patient) and other (1 patient). ''Other'' risk factors for spontaneous abortions were defined as the following; chlamydia infection with complicated pregnancy. Risk factors for stillbirth included the following; advanced maternal age equal or $g35 years (5 patients), smoking (3 patients), history of intrauterine fetal death (2 patients), diabetes mellitus type 1 (1 patient), history of gestational diabetes (1 patient), alcohol or drug use (4 patients), obesity (3 patients) and other (7 patient). ''Other'' risk factors for stillbirth included the following; congenital malformations in past pregnancies, uncontrolled diabetes, chronic hypertension, positive Down Syndrome screening and macrocytic hyperchromic anaemia. From 01-Oct-2009 through 28-Feb-2010, VAERS received a total of 10,186 reports after H1N1 vaccination; 422 of these reports involved pregnant women. The author excluded 128 pregnancy reports in which no AE was reported after the administration of inactivated or live H1N1. These pregnant women are being followed up prospectively as part of a separate CDC (Centres for Disease Control and Prevention) study that seeks to assess delivery and infant outcomes. Of the remaining 294 reports, 31 reports (10.5%), the seasonal influenza vaccine was administered on the same date at the H1N1 (WAVES 2011030537). Of the 294 reports, the median maternal age was 30 years (range 15 - 46 years). Median onset interval (adverse event onset date and vaccination date) was 2 days (range 0 - 84 days). Median gestational age at time of H1N1 vaccination was 13 weeks (range 3 - 39 weeks). The H1N1 was reported as administered mostly during the first (133; 53.8%) and second trimester of pregnancy (67; 27.1%). Sixty reports (20.4%) were coded as serious, including 2 maternal deaths. Serious reports corresponded to 59 pregnant women who were hospitalized for any reason and 1 to an infant born with a congenital anomaly. The most frequent pregnancy-specific AE reported following H1N1 administration was SAB (spontaneous abortion) in 121 women (41.2% of reports), followed by stillbirth in 19 women (6.5% of reports), preterm delivery of 7 women (one case where the infant of one mother died approximately one month after delivery), threatened abortion in 4 women, preterm labor in 3 women, maternal death in 2 women, preeclampsia in 2 women, intrauterine growth restriction in 2 women, fetal hydronephrosis in 1 woman, fetal tachycardia in 1 woman, cleft lip in 1 woman, neonatal intraparenchymal hemorrhage in 1 woman and intrauterine fetal death in 1 woman. Most SAB reports (n = 62) were received in Nov-2009 but reporting rapidly declined thereafter. All stillbirths were reported during Oct-2009 and Nov-2009 with 10 and 9 reports, respectively. In 42.4% of the SAB reports, the onset interval from the day of vaccination to onset of AE was 0-3 days (61 reports with onset of 0-6 days). In 47.4% of stillbirth reports, the onset interval was 0-6 days. The author did not observe any clustering of SAB or stillbirth cases by geographic location or lot number. Ninety-five SABs (78.5%) and 18 stillbirths (94.7%) were verified by review of medical records. Five fetal adverse outcomes were reported: 2 cases of intrauterine growth restriction and 1 case each of hydronephrosis, tachycardia, and cleft lip. The maternal deaths included 1 patient who experienced hemorrhagic shock because of uterine atony following a cesarean section and 1 patient who experienced a ruptured aortic aneurysm, which resulted in cardiac tamponade and subsequent death. A mild fetal hydronephrosis was detected in the patient during an ultrasound exam at 36 weeks'' gestation. However a postnatal ultrasound examination of the infant performed on day 2 of life failed to confirm the presence of hydronephrosis. Cause of death was not reported. Only 1 congenital anomaly was reported to VAERS: a cleft lip in an infant born to a 23 year old woman who was vaccinated at 19 weeks'' gestation. The cleft lip was first detected during a prenatal ultrasound examination at 22 weeks'' gestation. Cause of death was not reported. Because cleft lip was embryologically determined during the first trimester of pregnancy, it is implausible to consider vaccination at 19 weeks'' gestation as a possible causative agent. The most common non pregnancy specific AEs were non anaphylactic allergic reactions (36), constitutional symptoms (28), and local reactions (10). Two hundred thirty-five of the total reports (79.9%) did not require hospitalization. Five cases of Bells'' palsy and 1 case of anaphylaxis (meeting Brighton Collaboration case definition) were reported. No cases of Guillain-Barre syndrome were identified. There were 8 cases of paraesthesia''s, 5 cases each of syncope and dizziness, 3 cases each of hypoesthesia and headache and 25 cases of ''other'' Other events included anxiety, arthralgia, asthenia, asthma, arthritis, blurred vision, chest pain, chronic bronchitis, cough, diarrhoea, dyspnoea, eye swelling, influenza, influenza-like illness, lip injury, nail bleeding, panic attack, shingles, sneezing, tachycardia, tremors, unusual taste, upper respiratory tract and wheezing. One hundred twenty-one cases of SAB after H1N1 vaccination were reported to VAERS of which 95 were verified. Medical records were not received for 16 reports, and in 10 reports, the available records were not sufficient to confirm the initial diagnosis of SAB. Risk factors for SAB were identified in 47 (49.5%) of the 95 verified reports. Thirty-six women had only 1 risk factor for SAB. The most common risk factor was advanced maternal age (defined as age $g or = 35 years) in 25 reports (26.3%). Nineteen stillbirths were reported to VAERS. Of 18 with verified diagnosis, 13 (72.2%) had at least 1 maternal risk factor for stillbirth (eg, obesity) or a pathological finding that may have contributed to the fetal demise. Fourteen of 18 reports had pathology reports. Pathological/placental or other findings were present in 13 of the 14 reports and included chorioamnionitis in 7 reports and 2 reports each of tight nuchal cord, fetal-maternal hemorrhage, and fetal growth restriction. Of note, the 6 adverse event cases involving live H1N1 included 1 case of spontaneous abortion, 2 cases of general/constitutional symptoms, 1 case each of dizziness, headache, and ''other''. The event outcome was not reported.


VAERS ID: 449138 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-06
Entered: 2012-02-08
   Days after submission:2
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: 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: Not reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201201249

Write-up: Initial report was retrieved via the scientific literature on 30 January 2012. From the published article: Objective: The objective of the study was to evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), in pregnant women who received H1N1 to assess for potential vaccine safety problems. Study Design: The authors reviewed reports of adverse events (AEs) in pregnant women who received H1N1 vaccines from Oct. 1, 2009, through Feb. 28, 2010." Results: The results found 422 reports which involved pregnant women. Of the 422 reports, 128 were reports in which there were no AEs were reported. Of the remaining 294 reports, 288 had received inactivated vaccines and 6 had received lived vaccines. Medical records were obtained for 240 reports (81.6%). Sixty reports (20.4%) were coded as serious, including 2 maternal deaths. Serious reports corresponded to 59 pregnant women who were hospitalized for any reason and one to an infant born with a congenital anomaly. Of the reported cases 121 women had spontaneous abortions (at less than 20 weeks gestation) with onset interval from the day of vaccination to onset of AE reported as 0-3 days (61 reports with onset of 0-6 days). Stillbirths were reported in 19 women with the onset interval from the day of vaccination to onset of AE was 0-6 days. It was noted that there was no observed clustering of spontaneous abortions or stillbirth cases by geographic location or lot number. There were two maternal deaths which included one patient who experienced hemorrhagic shock because of uterine atony following a cesarean section and one patient who experienced a ruptured aortic aneurysm, which resulted in cardiac tamponade and subsequent death. Other pregnancy-specific outcomes reported included: preterm delivery, threatened abortion, preterm labor, preeclampsia, intrauterine growth restriction, fetal hydronephrosis (which was later determined not to be present), fetal tachycardia, neonatal intraparenchymal hemorrhage and intrauterine fetal death. The most common nonpregnancy specific AEs were nonanaphylactic allergic reactions, constitutional symptoms, and local reactions. Other non-pregnancy-specific outcomes reported included: paresthesias, Bell''s palsy, syncope, dizziness, hypoesthesia, headache and one case of anaphylaxis. There were no cases of Guillain-Barre syndrome identified. Conclusion: During October 2009 through February 2010, approximately 3% of reports to VAERS after H1N1 vaccine were of pregnant women who experienced at least 1 AE after vaccination. Among 294 VAERS reports of AEs in pregnant women after H1N1 vaccination with inactivated and live vaccines, the authors did not observe any unusual patterns of adverse maternal or fetal outcomes. The reporter for this case is also the reporter for case 2012-01250. Documents held by sender: none.


VAERS ID: 449871 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-02-17
Entered: 2012-02-20
   Days after submission:3
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: Caesarean section, Death, Live birth, Maternal exposure during pregnancy, Post procedural complication, Shock haemorrhagic, Uterine atony
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (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: Caesarean section
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012US012947

Write-up: Case number PHHY2012US012947 is an initial literature report received on 14 Feb 2012. The authors published the adverse events following administration of H1N1 to pregnant women that were reported to Vaccine Adverse Event Reporting System (VAERS). This case refers to a female patient (age not specified). She was vaccinated with H1N1 (manufacturer and batch number: unknown) between 01 Oct 2009 to 28 Feb 2010. She was pregnant at the time of vaccination. On an unspecified date she had a cesarean section and she gave birth to a live neonate. Following caesarean the patient experienced uterine atony which led to hemorrhagic shock. The patient died due to hemorrhagic shock. The causality of the case was not reported. The authors stated that the VAERS database search did not reveal any clustering of spontaneous abortions, still births or congenital anomalies. Authors concluded that the pregnant women who were vaccinated with H1N1 inactivated and live vaccines did not show unusual pattern of maternal or fetal outcomes.


VAERS ID: 452453 (history)  
Form: Version 1.0  
Age: 0.78  
Sex: Male  
Location: Kentucky  
Vaccinated:2012-02-20
Onset:0000-00-00
Submitted: 2012-03-26
Entered: 2012-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4231B / 2 LL / UN

Administered by: Public       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-03-26
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: Cold; No routine med
Preexisting Conditions: Baby born 3 wks premature
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Baby died at home DOA at hosp.


VAERS ID: 454494 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031599

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, pre-existing conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained for all patients from whom S. aureus was isolated from one of the designated sites. We focused out analyses on those patients from who S. aureus was isolated from a specimen collected within three days of hospital admission. as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC of the 88 children, 47 (53%) were boys and the medical age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age (Figure 1). Fifty-six (66% of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (2 0f 6) refers to 6 of 11 children who were completely vaccinated. S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolated were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454497 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   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, Influenza virus test positive
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: 2012031422

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates was performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, preexisting conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile (blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained for all patients from whom S. aureus was isolated from one of the designated sites. We focused our analyses on those patients from whom S. aureus was isolated from a specimen collected within three days of hospital admission, as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC. Of the 88 children, 47 (53%) were boys and the median age at death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age. Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (1 of 6) relates to 6 of 11 children who were completely vaccinated. Authors comment: S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolates were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454503 (history)  
Form: Version 1.0  
Age: 38.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
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, Respiratory failure
SMQs:, Anaphylactic reaction (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), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Immunocompromised
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031837

Write-up: This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (4 of 10) concerns a 38-year-old male patient, who had a medical history of immunodeficiency. The patient died of respiratory failure (under review), nineteen days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454505 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
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: 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: Febrile seizures (one after measles, mumps, rubella vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031818

Write-up: This literature report concerns a series of 10 cases of fatalities after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (1 of 10) concerns a 1-year-old male patient, who had a medical history of febrile seizures after mumps/measles/rubella. The patient died of sudden death, with no evidence of trauma, one day after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporter comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454521 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
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: Cardio-respiratory arrest, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Encephalopathy; Central apnea; Traumatic brain damage; Seizures
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031835

Write-up: This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (2 of 10) concerns a 2-year-old female patient, who had a medical history of encephalopathy, central apnea, traumatic brain damage, seizures. The patient died of sudden death cardiopulmonary arrest after H1N1 vaccination (type: monovalent inactivated, split-virus vaccine; manufacture: unknown). Time to onset was 0 day. Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454522 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   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
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: 2012031680

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates was performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, preexisting conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile (blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained from all patients from whom S. aureus was isolated from one of the designated sites. We focused our analyses on those patients from whom S. aureus was isolated from a specimen collected within three days of hospital admission, as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC. Of the 88 children, 47 (53%) were boys and the median age at death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age. Most were white. Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received as least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (case 1 of 4) relates to 4 of 11 children whose vaccination status could not be determined, but they received at least one dose of vaccine. Authors comment: S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolates were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454523 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   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, Influenza virus test positive
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: 2012031677

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, pre-existing conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained for all patients from whom S. aureus was isolated from one of the designated sites. We focused out analyses on those patients from who S. aureus was isolated from a specimen collected within three days of hospital admission. as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC of the 88 children, 47 (53%) were boys and the medical age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age (Figure 1). Fifty-six (66% of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (5 of 6) relates to 6 of 11 children who were completely vaccinated. S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolated were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454525 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
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, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (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), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Rett syndrome; Severe muscle wasting; Physical disability
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031836

Write-up: This literature report concerns a series of 10 cases of fatalities after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (3 of 10) concerns a 19-year-old female patient, who had a medical history of Rett syndrome and severe muscle wasting/physical disability. The patient died of Bilateral pneumonia and respiratory failure, nine days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454526 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   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, Influenza virus test positive
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: 2012031683

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, pre-existing conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained for all patients from whom S. aureus was isolated from one of the designated sites. We focused out analyses on those patients from who S. aureus was isolated from a specimen collected within three days of hospital admission. as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC of the 88 children, 47 (53%) were boys and the medical age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age (Figure 1). Fifty-six (66% of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (4 of 4) relates to 4 of 11 children whose vaccination status could not be determined, but they received at least one dose of vaccine. S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolated were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454529 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   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, Influenza virus test positive
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: 2012031681

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, pre-existing conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained for all patients from whom S. aureus was isolated from one of the designated sites. We focused out analyses on those patients from who S. aureus was isolated from a specimen collected within three days of hospital admission. as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC of the 88 children, 47 (53%) were boys and the median age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age (Figure 1). Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (2 0f 4) relates to 4 of 11 children whose vaccination status could not be determined, but they received at least one dose of vaccine. S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolated were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454530 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   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, Influenza virus test positive
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: 2012031676

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, pre-existing conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained for all patients from whom S. aureus was isolated from one of the designated sites. We focused out analyses on those patients from who S. aureus was isolated from a specimen collected within three days of hospital admission. as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC of the 88 children, 47 (53%) were boys and the median age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age (Figure 1). Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (4 0f 6) relates to 6 of 11 children who were completely vaccinated. S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolated were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454531 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   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, Influenza virus test positive
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: 2012031678

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates was performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, preexisting conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile (blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained from all patients from whom S. aureus was isolated from one of the designated sites. We focused our analyses on those patients from whom S. aureus was isolated from a specimen collected within three days of hospital admission, as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC. Of the 88 children, 47 (53%) were boys and the median age at death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age. Most were white. Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (case 6 of 6) related to 6 to 11 children who were completely vaccinated. Authors comment: S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolates were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454532 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   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, Influenza virus test positive
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: 2012031679

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, pre-existing conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained for all patients from whom S. aureus was isolated from one of the designated sites. We focused out analyses on those patients from who S. aureus was isolated from a specimen collected within three days of hospital admission. as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC of the 88 children, 47 (53%) were boys and the median age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age (Figure 1). Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case relates to 1 of 11 children who was partially vaccinated. S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolated were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454533 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
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, Influenza A virus test negative, Pulmonary embolism
SMQs:, Embolic and thrombotic events, 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:
Current Illness:
Preexisting Conditions: Hyperlipidemia; Hypertension; Pulmonary embolism; Deep vein thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031838

Write-up: This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (5 of 10) concerns a 46-year-old female patient, who had a medical history of hypertension, hyperlipidemia, pulmonary embolism and deep vein thrombosis. The patient died of pulmonary embolus (negative for H1N1 in lung tissue) two days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine;manufacturer: unknown). VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipts of H1N1 vaccine: 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454534 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   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, Influenza virus test positive
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: 2012031682

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates was performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, preexisting conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile (blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained from all patients from whom S. aureus was isolated from one of the designated sites. We focused our analyses on those patients from whom S. aureus was isolated from a specimen collected within three days of hospital admission, as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC. Of the 88 children, 47 (53%) were boys and the median age at death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age. Most were white. Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (case 3 of 4) relates to 4 of 11 children whose vaccination status could not be determined, but they received at least one dose of vaccine. Authors comment: S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolates were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 454535 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
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: Accidental death, Road traffic accident
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Driver involved in motor vehicle crash leaving clinic after H1N1 vaccination.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031841

Write-up: This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involve 2 children, 7 adults and 1 elderly reported. This case (7 of 10) concerns a 56-year-old female patient, who was involved in motor vehicle crash leaving clinic after H1N1 vaccination and died of trauma. Vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Time to onset was 0 day. Reporter''s comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of death occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454537 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
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: Bacterial sepsis, Cardio-respiratory arrest, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypertension; Diabetes; Peripheral vascular disease; End stage renal disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031842

Write-up: This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly. This case (9 of 10) concerns a 61-year-old male patient, who had a medical history of hypertension, diabetes, peripheral vascular disease and end stage renal disease. The patient died of cardiac / respiratory arrest and gram-negative sepsis, 13 days after H1N1 vaccination (type: monovalent, inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporters comments: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454538 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
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, 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: Lung cancer; Hypertension; Recurrent deep venous thrombosis; Atrial fibrillation; Hyperlipidemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031844

Write-up: This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly. This case (10 of 10) concerns a 77-year-old male patient, who had a medical history of lung cancer, atrial fibrillation, recurrent deep venous thrombosis, hypertension and hyperlipidemia. The patient died of suspected myocardial infarction, two days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine: manufacture: unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454540 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
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: Cardiovascular disorder, Death
SMQs:, 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: Type 2 diabetes; Stroke; Chronic obstructive pulmonary disease; Emphysema; Substance abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031839

Write-up: This literature report concerns a series of 10 cases of fatalities after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (6 of 10) concerns a 49-year-old patient, who had a medical history of Type 2 diabetes, stroke, chronic obstructive pulmonary disease, emphysema and substance abuse. The patient died of a suspected cardiovascular event three days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacturer: unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454541 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
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
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: End-stage renal disease; Atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012031840

Write-up: This literature report concerns a series of 10 cases of fatalities after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly reported. This case (7 of 10) concerns a 53-year-old female patient, who had a medical history of end-stage renal disease and atrial fibrillation. The patient died (of unknown cause) (under review), five days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).


VAERS ID: 454552 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-04-24
Entered: 2012-04-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Influenza, Influenza virus test positive
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: 2012031675

Write-up: This literature report concerns a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007-2008 influenza season. A case was defined as the death of a resident aged <18 from October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza virus type A or B infection. A positive laboratory test for influenza type A or B could occur before or after death and may be determined by any of the following methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay, fluorescent antibody staining, immunohistochemical staining of tissue samples, or reverse transcription polymerase chain reaction. Specimens for bacterial and viral culture were collected as part of routine clinical care and the postmortem examination, when applicable. CDC requested that respiratory specimens and postmortem lung specimens were sent to CDC laboratories if available. Influenza virus isolates, other viral isolates, and bacterial isolates were characterized at local, hospital, state, or CDC laboratories. Genotyping of available S. aureus isolates was performed at CDC by pulsed field gel electrophoresis (PFGE) using SmaI-digested DNA. Gel patterns were analyzed as previously described. State or local health departments completed a standardized reporting form for each case of influenza-associated pediatric mortality and transmitted the information to CDC via a web-based interface hosted on CDC''s Secure Data Network. Through the standardized reporting form, information was collected on patient demographics, influenza laboratory test results, date and location of death, preexisting conditions, complications during the acute illness (including radiologically confirmed pneumonia), influenza vaccination history, and results of bacterial cultures obtained from normally sterile (blood, pleural fluid, chest tube fluid, or cerebral spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal aspirates, and bronchial washes) sites. Information was not collected on bacterial cultures obtained from nares or sputum, as positive cultures from these sites are more likely to represent colonization rather than infection. The reporting form includes a notes section for reporting additional information and for clarification. Information regarding bacterial isolation from postmortem lung biopsies and fungal co-infections was not directly solicited; however, this information could be reported in a notes section of the reporting form. For our analysis, bacterial isolation from postmortem lung biopsies were included only if the specimen was collected on the calendar day of death or the calendar day following death. Dates of hospital admission and specimen collection were obtained from all patients from whom S. aureus was isolated from one of the designated sites. We focused our analyses on those patients from whom S. aureus was isolated from a specimen collected within three days of hospital admission, as we were attempting to identify patients in whom a bacterial co-infection may have contributed to their severe presentation (as opposed to having been acquired during hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric deaths were reported to CDC. Of the 88 children, 47 (53%) were boys and the median age at death was 5. Forty-two (47%) of the children were <5 years of age, and 14 (16%) were <1 year of age. Most were white. Fifty-six (66%) of 85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children received at least one dose of influenza vaccine in the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children, six were completely vaccinated, one was partially vaccinated, and complete vaccination status could not be determined in four. One child who received the vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for vaccination. This case (case 3 of 6) relates to 6 of 11 children who were completely vaccinated. Authors comment: S. aureus continues to be the most common bacteria isolated from children with influenza-associated mortality. S. aureus isolates were associated with older age and lack of high-risk medical conditions. Healthcare providers should consider influenza co-infections with S. aureus when empirically treating children with influenza and severe respiratory illness.


VAERS ID: 458211 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-06-25
Entered: 2012-06-27
   Days after submission:2
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: Cardiomyopathy, Death
SMQs:, Cardiomyopathy (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: PHHY2012US053744

Write-up: Case number PHHY2012US053744 is an initial literature report received on 20 Jun 2012. Authors searched for adverse events following H1N1, which were reported to the the Vaccine Adverse Event Reporting System from 01 Oct 2009 to 31 Jan 2010. This case refers to a patient (age and sex not reported). The patient was vaccinated with H1N1 (manufacturer and batch number: unknown) on an unspecified date. On an unknown date after vaccination the patient died due to cardiomyopathy. The causality of the event cardiomyopathy was not reported. Authors stated that the adverse event profile after H1N1 in VAERS was consistent with that of seasonal influenza vaccines, although the reporting rate was higher after H1N1 than seasonal influenza vaccines, this may be, at least in part, a reflection of stimulated reporting. Death, Guillain Barre Syndrome and anaphylaxis reports after H1N1 vaccination were rare (each <2 per million doses administered).


VAERS ID: 458218 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-06-25
Entered: 2012-06-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Heart disease congenital
SMQs:, Congenital, familial and genetic 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: Heart disease congenital
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012US053750

Write-up: Case number PHHY2012US053750 is an initial literature report received on 20 Jun 2012. Authors searched for adverse events following H1N1, which were reported to the Vaccine Adverse Event Reporting System from 01 Oct 2009 to 31 Jan 2010. This case refers to a patient (age and sex not reported). The patient''s medical history included of congenital heart disease (not specified). The patient was vaccinated with H1N1 (manufacturer and batch number: unknown) on an unspecified date. On an unknown date after vaccination the patient died to congenital heart disease. No other information was available. Authors stated that the adverse event profile after 2009-H1N1 in VAERS was consistent with that of INFLUENZA, although the reporting rate was higher after 2009-H1N1 than INFLUENZA, this may be, at least in part, a reflection of stimulated reporting. Death, Guillain Barre Syndrome and anaphylaxis reports after 2009-H1N1 vaccination were rare (each <2 per million doses administered).


VAERS ID: 458346 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-06-28
Entered: 2012-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Neurodevelopmental disorder; Nervous system disorder; Physical disability; Cerebral palsy; Mental disability
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012US054996

Write-up: Case number PHHY2012US054996 is an initial literature report received on 25 Jun 2012. Authors presented the importance of clinicians alertness to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. This case refers to a patient (age and sex not specified). The patient''s medical history included severe to profound neurologic and neurodevelopmental disabilities, including physical limitations, cerebral palsy and intellectual disability. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on an unspecified date during Oct 2010 to Nov 2010. On an unspecified date after vaccination, the patient developed influenza. On an unknown date the patient died due to multiple organ failure. No other information pertaining to this patient was available. Authors concluded that clinicians should be alert to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. Prompt testing and early empiric antiviral treatment in residents with respiratory symptoms in residential or long-term care facilities is important. Influenza prevention efforts should include vaccination of residents, health-care personnel, and others who might transmit influenza to residents, use of infection control precautions, and appropriate use of antiviral medications.


VAERS ID: 464129 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-08-31
Entered: 2012-09-05
   Days after submission:5
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: 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: Of the 411 diagnosed with probable or confirmed GBS, combined past medical histories included prior episode of GBS, diabetes mellitus, other immune disorder (including liver failure/cirrhosis, thyroid disease, systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, human immunodeficiency virus/acquired immunodeficiency syndrome, chemotherapy, neuropathy, and receipt of a transplanted organ), and cancer (including solid tumors such as breast, ovarian, and lung cancers, malignant melanoma, and hematologic malignancies).
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201207887

Write-up: Initial report was received via a search of the scientific literature on 23 August 2012. The following information is per the report: Active, population-based surveillance for GBS cases in persons who had an initial health-care encounter between October 1, 2009, and May 31, 2010, was conducted among 44.9 million residents at the 10 sites of the Emerging Infections Program (EIP). Each EIP site established a surveillance network comprised of neurologists and other health-care providers that was queried weekly to stimulate reporting of suspected GBS cases; hospital discharge data were also reviewed (International Classification of Disease, Ninth Revision) to capture additional cases not reported through the provider network. Trained surveillance officers reviewed medical records to gather standardized information on patient characteristics, clinical presentation, and medical history for every suspected GBS case. Suspected cases of GBS were evaluated by surveillance officers according to criteria established by the Brighton Collaboration. Patients with confirmed (Brighton levels 1 and 2) and probable (Brighton level 3) GBS were included in the analysis. Results: Among 44.9 million persons under surveillance from October 1, 2009, to May 31, 2010, study personnel identified 707 suspected GBS cases; 282 (40%) did not meet the Brighton criteria. Among the remaining 425 patients, a total of 411 GBS cases were included in the analysis (349 confirmed and 62 probable); 14 patients with GBS onset dates prior to October 1, 2009, were excluded. Eighty-five percent of GBS cases were aged $g/= 25 years; 52% were male, 15% required mechanical ventilation, and 3% died. Of the 411 total cases of confirmed or probable GBS, 408 patients received pH1N1 vaccine [29 patients (27 confirmed and 2 probable) received pH1N1 vaccine during the 42 days prior to symptom onset; 379 patients received it outside of the 42 day timeframe] and 371 patients received seasonal vaccine [36 patients (30 confirmed and 6 probable) received pH1N1 vaccine during the 42 days prior to symptom onset; 335 patients received it outside of the 42 day timeframe]. Among the 29 patients who received pH1N1 vaccine during the 42 day timeframe, there were 17 cases where 1 or more antecedent events were documented. Also of the 29 cases, 11 patients experienced upper respiratory or influenza-like symptoms, 5 experienced mechanical ventilation, and 1 patient had a medical history of a prior episode of GBS. Among the 36 patients who received seasonal vaccine during the 42 day timeframe, there were 24 cases where 1 or more antecedent events were documented. Also of the 36 cases, 21 patients experienced upper respiratory or influenza-like symptoms and 4 experienced mechanical ventilation. (Specific antecedent events included: upper respiratory or influenza-like symptoms, fever, gastrointestinal symptoms, seasonal influenza vaccine, and noninfluenza vaccination.). There were a total of 11 cases of death. In the group of 408 patients who received pH1N1 vaccine, there was 1 fatal case within the 42 day timeframe and 10 fatal cases outside of the 42 day timeframe. In the group of 371 patients who received seasonal vaccine, there was 1 fatal case within the 42 day timeframe and 8 fatal cases outside of the 42 day timeframe. History of pH1N1 vaccination was ascertained for 408 GBS cases (99%), of whom 67 (16%) received pH1N1 vaccine. Of these 67 patients, pH1N1 vaccine was received during the 42 days prior to GBS onset for 29 (43%), more than 42 days prior to onset for 34 (51%), and after GBS onset for 4 (1%). Fifty-seven patients (85%) received inactivated vaccine, 4 (6%), the vaccine type was unknown. pH1N1 vaccination status was ascertained by means of vaccine administration records, state registries, or administering provider documentation for 79% of cases, with the remainder being ascertained by self-report. History of seasonal vaccination was ascertained for 90% (n=371) of GBS cases, of whom 131 (35%) received seasonal vaccine. Of these 131 patients, seasonal vaccine was received during the 42 days prior to GBS onset for 36 (27%), more than 42 days prior to onset for 90 (69%), and after GBS onset for 5 (4%). Sixty-nine patients (53%) received inactivated vaccine, 1 (1%) received live attenuated vaccine, and vaccine type was unknown for 61 (47%). Seasonal vaccination status was ascertained by means of documented sources for 63% of cases, with the remainder being ascertained by self-report. Five cases received both pH1N1 vaccine and seasonal vaccine during the 42 days prior to GBS onset. Among GBS cases receiving pH1N1 vaccine 1-84 days prior to GBS onset, the median interval between vaccine receipt and disease onset was 27 days. The most likely cluster identified using the scan statistic was 29 cases occurring during days 1-37, but this cluster was not statistically significant (P=0.13). For seasonal vaccine, the median interval was 36 days, and no statistically significant cluster was identified. Generally, demographic characteristics, medical history, and outcomes for GBS cases did not differ by vaccine status, although antecedent events were less common among cases who received pH1N1 vaccine during the 42 days prior to onset than among those who did not (59% vs. 79%; P = 0.02). Examination of specific types of antecedent events showed that upper respiratory or influenza like symptoms were the only category of antecedent event that was significantly less common among cases who received pH1N1 vaccine than among those who did not (38% vs. 67%; P < 0.01). The total number of observed GBS cases in the EIP catchment area (n = 411) was similar to the expected number for the surveillance population (age-adjusted observed/expected ratio = 1.21, 95% confidence interval (CI): 0.78, 1.81), as well as among persons aged <25 years and $g=25 years. Authors estimated that there was less than 1 excess GBS case per million doses of pH1N1 vaccine administered and concluded that given the magnitude of morbidity and mortality associated with influenza infection, these findings provide reassurance that the excess risk of GBS following receipt of the pH1N1 vaccine was small compared with the morbidity and mortality prevented through the widespread use of the vaccine. Documents held by sender: None.


VAERS ID: 467381 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-10-03
Entered: 2012-10-03
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
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: PHEH2012US018706

Write-up: Case number PHEH2012US018706, is an initial spontaneous report received from a consumer on 21 Sep 2012 with a follow up information received on 24 Sep 2012: This report refers to a female patient whose age was not reported. She was vaccinated with influenza vaccine (unknown manufacturer and batch number) on an unknown date. On an unspecified date she died following a flu shot. Cause of death was not reported. Causality assessment was not reported. No further information was provided. Follow up information received on 24 Sep 2012: Gender of the patient was updated.


VAERS ID: 475315 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-11-26
Entered: 2012-11-27
   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: Autopsy, Death, Glioblastoma multiforme, Hyporeflexia, Immunoglobulin therapy, Metastases to meninges, Motor dysfunction, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging spinal cord abnormal, Paraesthesia, Respiratory disorder, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Respiratory failure (broad), Non-haematological malignant tumours (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: 2012033954

Write-up: This literature report (initial receipt: 13-Nov-2012) concerns a 49-year-old male patient. The patient had a recent history of viral infection status post flu vaccination (manufacturer, brand name and batch number were not provided). On an unknown date (post viral infection) the patient presented with a 2-week history of bilateral lower extremity weakness and paresthesias starting at the level of the axilla. He was evaluated by Neurology and initially diagnosed with transverse myelitis. He underwent intravenous immunoglobulin and steroid treatment without improvement. The patient''s physical examination revealed 3/5 proximal and 5/5 distal muscle strength in the lower extremities, deep tendon reflexes were 2/4 with no upper motor neuron signs visualized. He was medically stabilized and transferred to inpatient rehabilitation facility. Ten days post admission, the patient experienced acute motor loss (0/5) in bilateral lower extremities and worsening paresthesias, now involving bilateral upper extremities. At 10 days post admission, imaging revealed C7 to T2 diffuse cord expansion and an oval-shaped focus of intramedullary enhancement. Prior to the completion of his medical work-up, the patient passed away due to unclear causes. Death was most likely related to respiratory compromise. Post mortem autopsy results showed histopathological diagnosis of primary glioblastoma multiforme of the spinal cord. Reporter''s comment: This is a rare documented case of primary spinal glioblastoma multiforme in an adult patient. Mean survival time after onset is between 6-16 months. The major cause of death is leptomeningeal spread and cerebral metastasis. Cervical glioblastoma multiforme may have an even poorer outcome because of early involvement of the phrenic nerve nucleus and vasomotor centers.


VAERS ID: 476687 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-05
Entered: 2012-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Glioblastoma multiforme, Immunoglobulin therapy, Motor dysfunction, Muscular weakness, Neurological examination abnormal, Paraesthesia, Respiratory failure, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (broad), Respiratory failure (narrow), Non-haematological malignant tumours (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Neurological examination, see text
CDC Split Type: B0849218A

Write-up: This case was reported in a literature article and described the occurrence of glioblastoma multiforme in a 49-year-old male subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Influenza vaccine unspecified (unknown route, unknown lot number). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject presented with a 2-week history of bilateral lower extremity weakness and paresthesia starting at the level of the axilla. The subject had a recent history of viral infection status post flu vaccination. He was evaluated by Neurology and initially diagnosed with transverse myelitis. He underwent intravenous immunoglobulin and steroid treatment without improvement. The subject''s physical examination revealed 3/5 proximal and 5/5 distal muscle strength in the lower extremities, deep tendon reflexes were 2/4 with no upper motor neuron signs visualized. He was medically stabilized and transferred to our inpatient rehabilitation facility. Ten days post admission, the subject experienced acute motor loss (0/5) in bilateral lower extremities and worsening paresthesia, now involving bilateral upper extremities. At 10 days post admission, imaging revealed C7 to T2 diffuse cord expansion and an oval-shaped focus of intramedullary enhancement. Prior to the completion of his medical work-up the subject passed away due to unclear causes. The subject died from glioblastoma multiforme and respiratory failure. Post mortem autopsy results showed histopathological diagnosis of primary glioblastoma multiforme of the spinal cord.


VAERS ID: 482371 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Virginia  
Vaccinated:2012-10-24
Onset:0000-00-00
Submitted: 2013-01-24
Entered: 2013-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1206101W / 3 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Aphasia, Asthenia, Chest pain, Death, Gait disturbance, Guillain-Barre syndrome, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (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: Chronic kidney diseas, hypertension, gout
Allergies:
Diagnostic Lab Data:
CDC Split Type: VA13002

Write-up: Hospitalized 12/12/12 through 12/22/12 at medical center. Complaints of 6 months'' increasing edema in hands and feet, current unsteady gait, decreased strength. Diagnosed with Guillain-Barre Syndrome. Readmit 1/3/13 with worsening weakness, dysphasia. 1/5/13, expired during transport by ambulance. Stopped at community hospital while en route. DOA at community hospital. Medical center reporting seen at another medical center prior to current medical center 1/3/13 admission for chest pain. Ruled out MI at that time.


VAERS ID: 487277 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-03-05
Entered: 2013-03-20
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Death, Laboratory test normal, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013SE15191

Write-up: A report was received from a physician via a medical representative concerning a 3 year old female. Her medical history, concurrent diseases, and concomitant medications were not reported. On an unknown date, she received nasal FLUMIST. The medical doctor mentioned that two to three years ago a previously healthy 3 year old female died within three days of receiving FLUMIST in her office. The medical representative was uncertain whether symptoms began shortly after dose or three days later. At an unspecified time period after FLUMIST, the patient started vomiting and collapsed. She was taken to hospital three days after receiving FLUMIST and died. The physician stated that all the tests were negative, and the child was afebrile. The medical representative was uncertain whether an autopsy was performed. She also stated that the doctor thought the death was related to FLUMIST. The official cause of death was cardiac arrest. On an unspecified date, the patient died from the event of cardiac arrest, and at the time of reporting the outcome of the event of collapse and vomiting was unknown. According to the reporter the adverse event of cardiac arrest was considered to be serious with the serious criteria of death and the adverse event of vomiting was considered to be non-serious. According to the company physician the adverse event of collapse was considered to be serious with the serious criteria of important medical event. According to the reporter the adverse events were causally related to the suspect drug of FLUMIST.


VAERS ID: 491544 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-05-13
Entered: 2013-05-14
   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: Activities of daily living impaired, Anti-neuronal antibody negative, Antinuclear antibody negative, Areflexia, Ataxia, Athetosis, Blood thyroid stimulating hormone normal, CSF glucose normal, CSF protein increased, CSF white blood cell count negative, Cardiopulmonary failure, Cerebellar ataxia, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram abdomen normal, Computerised tomogram normal, Death, Decreased vibratory sense, Dizziness, Dyskinesia, Dysstasia, Electromyogram normal, Electrophoresis protein, Electrophoresis protein normal, Gait disturbance, Glycosylated haemoglobin normal, HIV test negative, Hepatic enzyme, Hypoaesthesia, Immunoglobulin therapy, Laboratory test abnormal, Loss of proprioception, Nerve conduction studies abnormal, Neurological symptom, Nuclear magnetic resonance imaging spinal normal, Paraesthesia, Peripheral sensory neuropathy, Radiculopathy, Romberg test positive, Somatosensory evoked potentials abnormal, Synovial cyst, Treponema test negative, Upper motor neurone lesion, Urine electrophoresis normal, Vitamin B12 normal
SMQs:, Cardiac failure (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Vestibular disorders (broad), Respiratory failure (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Congestive heart failure; Idiopathic pulmonary fibrosis
Allergies:
Diagnostic Lab Data: CSF analysis, Protein, 64.2 mg/dL, Elevated
CDC Split Type: 2013035891

Write-up: This literature report (initial receipt: 30-Apr-2013) concerns an 85-year-old male patient who had a medical history of congestive heart failure and idiopathic pulmonary fibrosis. He had no history of illicit drug use, excessive alcohol consumption, toxic exposures or family history of neurologic disorders. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not specified). On an unspecified date, 1 week after vaccination the patient developed tingling in his feet. 1 week later he developed a similar sensation in both hands. He reported difficulty unbuttoning his shirt and unsteadiness when walking. He had no prior similar symptoms, preceding illnesses, or recent changes in his health or medications. On examination, he had no cranial nerve deficits and full strength. He had preserved light touch, temperature, and pinprick sensation, but symmetrically diminished vibration sense and proprioception to the level of both wrists and ankles. Reflexes were absent bilaterally in his upper and lower extremities. On pronator drift testing, his arms drifted upward, and his fingers made small involuntary movements. On finger-nose testing the patient had difficulty reaching and maintaining contact with a target, which worsened with eyes closed. He had no Romberg sign, but had mild gait instability. The patient''s gait unsteadiness, upward drift of the arms with pseudoathetosis of the fingers (subtle movements suggestive of a proprioceptive deficit), and worsening of finger-nose testing with eyes closed suggest a sensory ataxia. Sensory ataxia, diminished vibration sense, decreased proprioception, and areflexia localized to the posterior columns, large fibers of peripheral nerves, or intervening dorsal root ganglia or nerve roots; the bilaterality, symmetry, and areflexia made a supratentorial etiology improbable. Before referral to the neurologist, the patient underwent laboratory evaluation for etiologies of peripheral neuropathy, revealing normal vitamin B12, thyroid stimulating hormone, hemoglobin A1C, serum and urine protein electrophoresis, and liver enzymes. Given the rapidly evolving nature of his symptoms and absent reflexes, he was admitted due to concern for possible Guillain-Barre syndrome (GBS). CSF analysis to assess for inflammation or infection revealed normal glucose (60 mg/dL), mildly elevated protein (64.2 mg/dL), and no red or white blood cells. Electromyography (EMG) and nerve conduction studies (NCS) were performed to distinguish between axonal and demyelinating etiologies of presumed polyneuropathy. NCS demonstrated reduced amplitudes of sensory nerve action potentials (SNAPs) in the sural (left 3.3 mV, right 0.60 mV), superficial peroneal (left 3.7 mV, right 3.3 mV), median (left 6.0 mV, right 6.1 mV), and ulnar nerves (left not recordable, right 5.2 mV); slightly reduced amplitudes of combined motor action potentials (CMAPs) of bilateral median (left 4.5 mV, right 2.5 mV), left ulnar (3.4 mV), and bilateral peroneal nerves (left 1.7 mV, right 1.9 mV); and normal nerve conduction velocities (NCV), distal latencies, and F waves. EMG was normal in bilateral tibialis anterior, left first dorsal interosseous, and left extensor digitorum brevis muscles. Due to the lack of weakness and bulbar symptoms and the NCS lacking features of demyelination with preserved F waves, GBS and subtypes of GBS including acute inflammatory demyelinating polyradiculoneuropathies (AIDP) and AIDP variants including Miller Fisher syndrome were ruled out. He underwent extensive but unrevealing evaluation for possible autoimmune, infectious, or paraneoplastic processes (serum antinuclear antibodies, SS-A [Ro], and SS-B [La]; rapid plasma reagin and HIV; anti-Hu, anti-GQ1B, and anti-GM1 autoantibodies; and computed tomography (CT) of the chest, abdomen, and pelvis). Although the etiology of his illness was unclear, intravenous immunoglobulin (IVIg) 0.4 g/kg/day was administered for 5 days. His symptoms remained stable and he was discharged for rehabilitation. He initially noted improvement in his gait and only minimal persistent numbness in his hands and feet. One month later, however, his gait acutely worsened over several days, such that he was too unsteady to walk or stand unassisted. He had a Romberg sign, swayed from side to side when standing, and had a magnetic gait. His sensory, motor, and reflex examinations were otherwise unchanged from his initial examination. The differential diagnosis of the patient''s progressive sensory symptoms includes chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and ganglionopathy. Ganglionopathy was diagnosed as it presents with sensory ataxia and deficits in proprioception and vibration sense with reduced SNAPs all seen in the patient. EMG/NCS were repeated and demonstrated relatively unchanged SNAPs and CMAPs compared to his prior NCS. Since worsening axonal neuropathy or ganglionopathy would have been expected to result in further decrement in his SNAPs, his clinical progression in the setting of stable electrodiagnostic studies suggested a more proximal lesion at the level of the nerve roots or posterior columns. In this patient, somatosensory evoked potentials (SSEPs) revealed no reproducible waveforms at any site. Given the presence of SNAPs on routine NCS, the absence of SSEPs suggests block of conduction more proximally (e.g., at the level of proximal nerve roots or posterior columns). Magnetic Resonance Imaging (MRI) of the spine with gadolinium was performed, demonstrating enhancement of numerous lumbosacral nerve roots and dorsal root ganglia with a normal-appearing spinal cord. Nerve biopsy was proposed, but deferred by the patient and his family. This constellation of clinical, electrodiagnostic, and imaging features is suggestive of chronic immune sensory polyradiculopathy (CISP). He was treated with another course of 5 days of IVIg followed by 1 g/kg over 2 days monthly for 4 months and prednisone 60 mg daily. His neurologic status did not improve with therapy, suggesting that he had developed irreversible damage to his proximal nerve segments. He died several months later from complications of his underlying cardiopulmonary disease.


VAERS ID: 494783 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-06-21
Entered: 2013-06-21
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0901016A

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in an adult subject of unspecified gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified 2011-2012 season (administration site and route unknown, batch number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified 2011-2012, the subject was hospitalised. The subject died from cause undetermined. It was unknown whether an autopsy was performed. Summary of the literature article: Annual influenza vaccine has been recommended for adults at high risk for influenza complications since 1960; universal vaccination has been recommended since 2010. Two recent reviews both reported that there is little evidence to support vaccine effectiveness against serious influenza complications for adults. Clinical trials have been too small to evaluate influenza complications, and most observational studies have not used laboratory-confirmed influenza as an outcome. The case-positive, control-negative study design is an efficient method to determine vaccine effectiveness that assures appropriate classification of cases and identifies controls with risk factors for both acute respiratory illness and propensity to seek medical care similar to those of influenza-positive patients. During the 2011-2012 influenza season, the authors enrolled hospitalized adults with acute respiratory illness and tested each for influenza using reverse transcription polymerase chain reaction. Influenza vaccination was verified in 35% (6/17) of adults with influenza-associated hospitalizations compared to 64% (97/152) of test-negative controls; adjusted vaccine effectiveness was 71.4% (95% confidence interval, 17.1% - 94.9%). Although the authors enrolled subjects with fairly broad eligibility criteria, discharge diagnoses were not associated with either influenza diagnosis or vaccination status. These data are among the first estimates of vaccine effectiveness for the 2011-2012 influenza season. More important, this study adds to the evidence indicating that inactivated influenza vaccine can prevent more than half of all influenza-associated hospitalizations in older adults. Influenza causes an average of 294 128 hospitalizations annually; most are in adults aged. 50 years. The authors''s conclusion stated that given current vaccination rates and a vaccine effectiveness of 60%, more than one-third of these hospitalizations could be prevented by increasing vaccination uptake in this population.


VAERS ID: 503830 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-24
Entered: 2013-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody positive, Death, Granulomatosis with polyangiitis, Renal failure chronic
SMQs:, Rhabdomyolysis/myopathy (broad), Interstitial lung disease (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Hypersensitivity (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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0923565A

Write-up: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 70-year-old male subject who was vaccinated with Influenza vaccine (unspecified) (unknown route, site of injection and batch number). On on unspecified date, the subject received unspecified dose of influenza vaccine (unspecified) (unknown route, site of injection and batch number). Three weeks after vaccination with Influenza vaccine (unspecified), the subject experienced anti-neutrophil cytoplasmic antibody positive vasculitis (perinuclear/myeloperoxidase), granulomatosis with polyangiitis which led to a end-stage renal disease. The kidney was the only organ involved. The subject was treated with cyclophosphamide and prednisone. At an unspecified date, the subject died. In the article, the cause of death of two fatal cases was reported (refractory vasculitis and bilateral pneumonia). However, no precision was available to link this case to one these two reported causes of death. This case is linked to 7 cases coming from the same publication.


VAERS ID: 504856 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2013-08-23
Onset:0000-00-00
Submitted: 2013-09-30
Entered: 2013-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK UN / UN
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Pyrexia, Surgery
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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MK-9041A
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309USA012570

Write-up: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On 23-AUG-2013 the patient was vaccinated with ZOSTAVAX, injection (dose, route and lot number unknown). Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (manufacturer unknown) and FLUZONE. On an unknown date in 2013 the patient experienced death, following unspecified surgery. The pharmacist stated that a physician (unspecified) called the pharmacy on 24-AUG-2013 and was inquiring about the 3(three) vaccinations that the patient had received. The physician stated that the patient had exhibited a fever. A request was made for the patient''s Primary Care Physician''s, name and contact information. A request was made for a copy of the patient''s Death Certificate and/or Autopsy Report. The pharmacist stated that there were several physician''s involved with the patient''s case. The pharmacist refused to give any information and stated that the patient''s information was being handled by Clinical Risk Management for Pharmacy. Relatedness between vaccination with ZOSTAVAX and death was not reported. Upon internal review surgery was considered medically significant. Additional information has been requested.


VAERS ID: 509086 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Illinois  
Vaccinated:2013-09-24
Onset:0000-00-00
Submitted: 2013-10-22
Entered: 2013-10-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Back pain, Death, Decreased appetite, Dehydration, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-02
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: Bone marrow disorder, did not make enough red blood cells
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2013SA103597

Write-up: Initial report was received from a healthcare professional on 07 October 2013. An 86-year-old female patient had received an injection of FLUZONE HIGH-DOSE (lot number, route and site of administration not reported) on 24 September 2013 and an unspecified amount of time following vaccination experienced decreased appetite, stomach and back pain, was dehydrated and had increased white blood cells. The patient passed away on 02 October 2013, 8 days post-vaccination. The patient had a history of a "bone marrow issue in that did not make enough red blood cells". No additional information was provided. Outcome was fatal. Documents held by sender: None.


VAERS ID: 513769 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Vermont  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-18
Entered: 2013-11-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Headache, Laboratory test, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: No pre-existing health conditions and was a very healthy child
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2013SA118114

Write-up: Initial report was received on 07 November 2013 from a non-health care provider from an unverified internet source. The reporter for this case is the same as case number 2013SA114788. A 7 year-old female patient (date of birth not reported) had received an Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) at her annual checkup. The patient was reported to have no pre-existing health conditions and was a very healthy child. The patient developed a severe headache and fever one day after vaccination. Three days later, the patient stopped breathing and died without warning in her mother''s arm. Diagnostic and laboratory testing were not reported. No further details were available at the time of the report. The patient''s outcome was fatal. Documents held by sender: None.


VAERS ID: 514612 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Female  
Location: Unknown  
Vaccinated:2013-10-01
Onset:0000-00-00
Submitted: 2013-11-25
Entered: 2013-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Brain death, Coagulopathy, Death, Dyspnoea, Feeling abnormal, Fluid retention, Gastrointestinal infection, Haemorrhage, Life support, Loss of consciousness, Platelet count decreased, Platelet transfusion, Renal failure, Septic shock, Swelling, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), 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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-02
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: Gabapentin; Herbal medication
Current Illness: Seizure
Preexisting Conditions: No relevant medical history
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A1050266A

Write-up: This case was reported by a consumer (patient''s mother) and described the occurrence of septic shock in a 48-year-old female patient who was vaccinated with Influenza vaccine (unspecified, manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included seizure. Concurrent medications included Gabapentin and Herbal medication. Co-suspect medication included LAMICTAL. In early 2012, the patient started Lamotrigine (oral) at 100 mg twice per day. In 2012, the patient initially experienced some numbness and tingling in her fingers (numbness in finger and tingling in finger) that made her fingers feel funny. She then was doing okay on Lamotrigine until she started having some light seizures over the last 6 months [2013]. As a result, the physician had just increased her dosase from 2 pills a day to 3 a day but the mother of the patient was not sure if she had actually started the increased dosage. In October 2013 the patient received a dose of Influenza vaccine unspecified (unknown). On the evening of 30 October 2013 the patient collapsed and lost consciousness. The patient never regained consciousness. She was taken to the hospital right away. The patient was hospitalised and it was discovered that the patient was hemorrhaging. She did not have any platelets in her blood (low platelet value) and when she was given platelets, her blood just was not clotting. She had a slight infection in her bowel, which cleared up within one day with antibiotics. The patient was also retaining fluid and was all swelled up and puffy. The patient was put on life support because she was not breathing properly. The patient''s kidneys failed on 01 November 2013 and on the 02 November 2013 her brain failed. She was therefore taken off life support on 02 November 2013 and died the same day. The death certificate listed septic shock as the cause of death. The patient''s mother reported that the doctors did not know what caused the septic shock but did not think it was medication-related. The patient had received the Influenza vaccine unspecified at work and within 2-3 weeks of the events leading to her death. According to the mother, the Influenza vaccine unspecified "may have triggered all of it." The patient had mentioned after receiving the vaccine that she "felt terrible/awfully bad afterwards" (onset less than 2-3 weeks after vaccination). At the time of reporting, the events were fatal. The patient died on 2 November 2013 from septic shock. It is unknown whether an autopsy was performed.


VAERS ID: 514858 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Washington  
Vaccinated:2013-11-23
Onset:0000-00-00
Submitted: 2013-11-26
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4787AA / UNK RA / IM
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. J006830 / UNK LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Meloxicam; Omeprazole; Ferrous sulfate
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient''s husband indicated she had reaction from vaccine and passed away. Do not have specific details.


VAERS ID: 517719 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-24
Entered: 2013-12-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, 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: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2013SA131895

Write-up: Initial report received from a healthcare professional (pharmacist) on 09 December 2013. This case is linked with cluster cases: 2013SA131929 and 2013SA131928 (Same vaccine, same reporter). A male patient, whose medical history and concomitant medications were not reported, had received a dose of Influenza QIV vaccine (manufacturer: not provided, lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date after vaccination, the patient developed Guillain Barre Syndrome and the patient was died. Laboratory investigations and corrective treatments were not reported. No autopsy details were reported. Documents held by sender: none.


VAERS ID: 518204 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-02
Entered: 2014-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Private       Purchased by: Private
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: Concomitant vaccinations, medications and relevant medical history were unknown. It was unknown if adverse events occurred with previous immunizations, including influenza vaccinations.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A1055013A

Write-up: This case was reported by a healthcare professional via sales representative and described the occurrence of death (cause unknown) in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in 2013 the subject received a dose of FLULAVAL (unknown). In 2013, 2 months after vaccination with FLULAVAL, the subject experienced death (cause unknown). The subject died on an unspecified date in 2013, cause of death was not unknown. It was unknown whether an autopsy was performed.


VAERS ID: 523158 (history)  
Form: Version 1.0  
Age: 0.53  
Sex: Female  
Location: Connecticut  
Vaccinated:2014-02-12
Onset:0000-00-00
Submitted: 2014-02-20
Entered: 2014-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4454BA / 3 RL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4692CA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH967AA / 3 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G98915 / 3 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J010970 / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-02-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Hemangioma; Atopic dermatitis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None - pt found unresponsive and deceased 2/20/14 approximately 5 AM.


VAERS ID: 524014 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-24
Entered: 2014-02-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose increased, Death, Diabetes mellitus inadequate control, Diabetic coma, Influenza
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: Diabetic
Allergies:
Diagnostic Lab Data: Flat-lined three times; blood glucose, Unknown, Unknown, Unknown
CDC Split Type: 2014SA022128

Write-up: Initial report was received on 20 February 2014 from an electronic lay press article. A 55 year-old male patient (date of birth not reported) with a history of diabetes had received an influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later developed the flu. The patient first became ill on a Thursday. "That afternoon, his blood sugar spiked, and they were unable to get it down. So they took him to the hospital and from there he flat - lined three times". By Friday night the patient was flown to another hospital where he died in a diabetic coma. Outcome was fatal. Documents held by sender: none.


VAERS ID: 529682 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-24
Entered: 2014-04-29
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Influenza, Influenza virus test, Polymerase chain reaction
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: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: The patient had undergone RT PCR test for the diagnosis of influenza.
CDC Split Type: 2014SA050495

Write-up: Initial report received from literature on 11 April 2014. A 6 adult patients of age below 65 years, whose concomitant medications were not reported, had received 2013-14 seasonal Influenza Vaccine (batch number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. The department of public health conducts surveillance on severe influenza like illness aged less than 65 years. This case includes the influenza with symptom onset on or after 29 September 2013 of 2013-14 influenza seasons. There were only 6 out of 28 patients whose vaccination status were known had received 2013-14 influenza seasonal vaccine greater than or equal to 2 weeks before symptoms onset. DPH sought the data from autopsy and medical records for fatal cases and reviewed available data for all severe cases for 2013-14 season vaccine. Data review includes patient''s demographics, clinical courses and treatment underlying medical conditions, influenza vaccination status and underlying medical conditions. There were 3 fatal influenza cases includes children aged less than 18 years and one fatal case includes a patient less than 5 years old. Of six patients with no known comorbid conditions predisposing them to complications from influenza, as defined by ACIP three were obese with body mass indices of 30-39. The data from 2013-14 influenza vaccination season indicates that the patients aged 41-64 years are at the higher risk of influenza. The antiviral treatment was underutilized by these patients and overreliance on rapid diagnostic test with poor sensitivity. The patient''s died on unspecified date. Documents held by sender: none.


VAERS ID: 545052 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2014-09-17
Onset:0000-00-00
Submitted: 2014-09-23
Entered: 2014-09-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U4995AA / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA130724

Write-up: Initial report was received on 19 September 2014 from a health care professional. A male patient reported over the age of 65 years (date of birth not reported) had received on an unspecified date FLUZONE HIGH DOSE, (lot number, route and site of administration not reported) and within 24 hours of receiving the vaccine suffered cardiac death. Outcome was fatal. Documents held by sender: none.


VAERS ID: 549873 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Michigan  
Vaccinated:2014-09-25
Onset:0000-00-00
Submitted: 2014-10-10
Entered: 2014-10-24
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5042AA / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Lung disorder, Pulmonary fibrosis, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-02
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: Pulmonary fibrosis; Former smoker; Former drinker
Allergies:
Diagnostic Lab Data: (To date, I am aware of 5 of my patients that have died within 6 months of getting high dose flu vaccine since 2010.)
CDC Split Type:

Write-up: Patient had severe lung disease and I did consider him terminal but he had high dose flu vaccine and died soon after getting vaccine. Vaccine given 9/25/14 and patient died 10/2/2014. Presumed cause of death respiratory failure with underlying pulmonary fibrosis.


VAERS ID: 555555 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Georgia  
Vaccinated:2014-10-02
Onset:0000-00-00
Submitted: 2014-11-12
Entered: 2014-11-25
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5024BA / 2 RA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Cardiac failure congestive, Death
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Wife states that her husband (patient) went into congestive heart failure and died a few days after receiving the flu vaccine.


VAERS ID: 557160 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-12-05
Entered: 2014-12-05
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, Myocarditis infectious
SMQs:, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHEH2014US024123

Write-up: Case number PHEH2014US024123, is an initial spontaneous report from a nurse received on 02 Dec 2014. This report refers to a 07 year old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal Influenza vaccine (manufacturer and batch number unknown) on an unknown date. On an unknown date, after vaccination, she experienced myocardial infection and died 4 days after vaccination. Outcome of the event myocardial infection was not reported. Cause of death and causality of the events was not reported. Seriousness assessment of myocardial infection was upgraded based on the NVS-IMS list. No additional information was available.


VAERS ID: 562167 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Texas  
Vaccinated:2014-10-01
Onset:0000-00-00
Submitted: 2015-01-09
Entered: 2015-01-23
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Influenza, Influenza A virus test positive, Pulmonary congestion, Pulmonary haemorrhage, Staphylococcal infection, Staphylococcus test positive
SMQs:, Cardiac failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-12-16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SE03919

Write-up: A report from a physician concerns a 13 year old female patient. Relevant history, concurrent diseases and concomitant drugs were not reported. The patient received FLUMIST QUADRIVALENT (intranasal) in Oct-2014 at a local pharmacy. Apparently patient had received FLUMIST QUADRIVALENT at an outside pharmacy, so the doctor doesn''t have information on lot number. Patient passed away on 16-Dec-2014. Patient was positive for influenza A. The parents requested an autopsy, and the preliminary report states following Diagnosis: 1. Congestive hemorrhagic lungs. 2. Influenza A. 3. Staphylococcus aureaus (+) from the lungs. Physician said that once they receive the final autopsy report they will notify our office. The patient died from the congestive hemorrhagic lungs on 16-Dec-2014. The outcome of the staphylococcus aureus (+) from lungs and influenza A was unknown. The cause of death was congestive hemorrhagic lungs. An autopsy was performed. The reporter considered the congestive hemorrhagic lungs to be serious by the criterion of death and other events to be serious by the life threatening criterion.


VAERS ID: 562739 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2014-11-19
Onset:0000-00-00
Submitted: 2015-01-27
Entered: 2015-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5024BA / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Multiple myeloma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death.


VAERS ID: 563861 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Nevada  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-01-29
Entered: 2015-02-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Cough, Death, Influenza, Life support, Pyrexia, Resuscitation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), 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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA010906

Write-up: Initial unsolicited report was received via a lay press article on 27 January 2015. A five year-old female patient (date of birth not reported) had received on an unspecified date an influenza vaccine (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later, experienced a cough and fever. The patient was seen in a clinic and prescribed steroids and a nebulizer. Hours later the patient collapsed and CPR was performed. The patient was found to have Influenza A. The patient was hospitalized and placed on life support. The patient suffered a cardiac arrest and died. Outcome was fatal. Documents held by sender: none.


VAERS ID: 564751 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: New York  
Vaccinated:2015-01-29
Onset:0000-00-00
Submitted: 2015-02-12
Entered: 2015-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. CL2126 / UNK NS / IN

Administered by: Private       Purchased by: Other
Symptoms: Abdominal pain, Culture urine negative, Death, Mental status changes, Pyrexia, Rash generalised, Ultrasound abdomen normal, Urinary tract infection, Viral infection, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-02-06
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Bilateral lower Abdominal pain
Preexisting Conditions: Aspergers
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Seen at PMD for adb pain (pt had menses at this time) on 1/30/15. Dx with UTI, started Bactrim and patient was stopped from meds after a few days due to neg urine cx and the patient also was feeling better. On Wed 2/4/15 the abd pain returned and the patient then developed a fever of 102.6 and an all over body rash (non-pruritic). Seen at PMD on that day and was dx with suspect viral illness. Abd ultrasound was also done at the PMD and negative. On Thurs 2/5 the patient came in to the hospital due to dramatic altered mental status and vomiting stomach contents. The mental status worsened throught out hospitalization. Patient passed away.


VAERS ID: 566449 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2009-10-06
Onset:0000-00-00
Submitted: 2015-02-23
Entered: 2015-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dyskinesia, Encephalitis, Guillain-Barre syndrome, Hypertension, Malaise
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: 2015048932

Write-up: This spontaneous consumer report (initial receipt 11-Feb-2015) concerns a female patient. On the 06-Oct-2009, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, the patient became very sick. The patient went into fetal position within 24 hours after vaccination and became hypersensitive, slided her legs out and moved her head in circles for weeks. Weeks later, the patient went to the medical centre and the doctor stated that she experienced Guillain Barre Syndrome and encephalitis. She was treated with antibiotics. The patient did not recover and passed away in Feb-2014. The exact cause of death was unknown. The outcome was reported as not recovered. Reporter''s comments: It was reported that the exact cause of death was unknown. The reporter did not specify how her mother passed away or if it was related to the flu vaccine.


VAERS ID: 566923 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-02-23
Entered: 2015-02-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Analgesic drug level increased, Autopsy, Brain oedema, Death, Decreased appetite, Hepatic steatosis, Influenza, Influenza A virus test positive, Renal tubular disorder, Reye's syndrome, Toxicity to various agents, Unresponsive to stimuli, Vomiting
SMQs:, Acute renal failure (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Tubulointerstitial diseases (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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:
CDC Split Type: US2015GSK022605

Write-up: This case was reported in a literature article and described the occurrence of vomiting in a 7-year-old male patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine (unknown). On an unknown date, 3 days after receiving Influenza vaccine, the patient experienced vomiting, appetite lost and influenza A virus infection. On an unknown date, the outcome of the vomiting, appetite lost and influenza A virus infection were unknown. The reported cause of death was Reye''s syndrome. An autopsy was performed. The autopsy determined cause of death was hepatic steatosis, kidney tubule disorder, cerebral edema, influenza A virus infection and salicylate intoxication. It was unknown if the reporter considered the vomiting, appetite lost and influenza A virus infection to be related to Influenza vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of vomiting in a 7-year-old male patient who had received unspecified influenza A vaccination (manufacturer unknown). No information on the patient''s medical or family history or concurrent condition was provided. On an unspecified date, the patient received unspecified influenza A vaccine (administration route and site unspecified; dosages unknown; batch numbers not provided). On an unspecified date, 3 days after receiving vaccination the patient developed profound vomiting and loss of appetite. The patient''s mother had given him PEPTO-BISMOL and Gatorade as treatment and sent the patient to bed. The patient was found unresponsive less than 12 hours later and pronounced dead 4 minutes after arrival at the hospital. Autopsy findings included diffuse mixed micro and macro vesicular steatosis of the liver, micro vesicular steatosis in the renal tubule cells, and cerebral edema. A postmortem nasopharyngeal swab screening was positive for influenza A. Toxicology was positive for salicylate. The outcomes of the events were unspecified. The authors did not comment on causality relationship between the vaccine and the event. The authors concluded that "Reye''s syndrome is a rare severe neurologic disorder consisting of a biphasic illness characterized by a viral infection followed by an acute onset of non-inflammatory encephalopathy and hepatic failure, with rapid progression to death if not properly treated. It most commonly affects children younger than 16 years of age who are treated with aspirin during certain viral infections, including varicella and influenza. The exact cause is unknown, but it is thought to result from mitochondrial impairment resulting from the actions of salicylate and its metabolites, hydroxyhippurate and gentisate. This impairment appears to be intensified during viral illnesses".


VAERS ID: 567070 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-02
Entered: 2015-02-25
   Days after submission:176
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Laboratory test, Microscopy, Neurological examination, Toxicologic test
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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions: Dizziness; Visual impairment; Cold sweat; Nausea
Allergies:
Diagnostic Lab Data: Autopsy and microscopic, neuropathological, toxicological, and chemical evaluation, the immediate cause of death: Could not be ascertained.
CDC Split Type: 2014SE67987

Write-up: A spontaneous health professional report from a regulatory authority in an article, concerns a 19 year old female. The patient''s medical history included cold sweat, nausea, dizziness, and difficulty reading numbers on the day prior to death. Concomitant medications included quadrivalent human papilloma virus vaccine and meningococcal conjugate. Patient received Nasal FLUMIST QUADRIVALENT on an unknown date. The patient died 10 days after these vaccinations from unknown causes. Despite an extensive post-mortem examination including autopsy and microscopic, neuropathological, toxicological, and chemical evaluation, the immediate cause of death could not be ascertained. Autopsy revealed no obvious cause of death. The reporter assessed the death to be serious by the criterion of death.


VAERS ID: 567073 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-02
Entered: 2015-02-25
   Days after submission:176
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Brain injury, Death
SMQs:, Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness: Atrial septal defect
Preexisting Conditions: Premature baby
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014SE68042

Write-up: A report from VAERS concerns a three year old male patient. The patient was born prematurely between gestational weeks 32 and 33 and suffered from atrial septal defect. The patient received nasal FLUMIST and 10 days later experienced hypoxic-ischemic brain injury. The patient died of the hypoxic-ischemic brain injury on an unknown date. It was unknown if autopsy was performed. The reporter assessed the event as serious due to death. Based on the information in this report, and awaiting the reporter''s assessment, the company physician considered the event to be at least possibly related to FLUMIST.


VAERS ID: 567086 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-02
Entered: 2015-02-25
   Days after submission:176
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014SE68022

Write-up: It is a spontaneous report to the VAERS program concerning a child patient with unknown gender and age. The patient''s medical history, concurrent diseases, and concomitant medications were not reported. On an unknown date, the patient received nasal FLUMIST. Two days after vaccination, the patient had a seizure, and the patient died. The cause of death was seizure. Interval after vaccination unknown. According to the reporter the seizure was considered to be serious with the serious criteria of death.


VAERS ID: 567087 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-09-02
Entered: 2015-02-25
   Days after submission:176
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Mental status changes, Subacute sclerosing panencephalitis
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (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, 16 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions: Subacute sclerosing panencephalitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014SE67999

Write-up: A spontaneous health professional report from a regulatory authority in an article. Vaccine Adverse Event Reporting System (VAERS), July 2013-April 2014, concerns a 7 year old female. The patient''s medical history included subacute sclerosing panencephalitis (SSPE). No concomitant diseases and concomitant medications were reported for consumer. Patient received Nasal FLUMIST QUADRIVALENT on an unknown date, and 64 days later she required hospitalization for 16 days for changes in mental status and progression of SSPE. The patient died from an unknown cause on an unspecified date. The report did not describe whether an autopsy was performed. The reporter assessed the death to be serious by the criterion of death.


VAERS ID: 567978 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Indiana  
Vaccinated:2014-09-26
Onset:0000-00-00
Submitted: 2015-02-26
Entered: 2015-03-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5024CA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chest X-ray, Death, Full blood count, Pneumonia, White blood cell count
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: 2014-10-17
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: Unk
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Chest X-ray results not reported. WBC, Unknown, Unknown; CBC, Unknown, Unknown
CDC Split Type: 2015SA023263

Write-up: Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" (eight of which were identified) received from the same reporter. The other patients are captured in cases 2014SA157362, 2015SA023267, 2015SA023893, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924 and 2015SA023928. A 73 year-old elderly male patient had received on 26 September 2014 an intramuscular left arm injection of FLUZONE HIGH DOSE (lot number U5024CA with expiration date of 12 May 2015) and an unspecified amount of time later was diagnosed with pneumonia and died 21 days after vaccination on 17 October 2014. The patient had a chest x-ray, WBC and CBC results were not reported. Illness at the time of vaccination was none. Concomitant medications and pre-existing conditions were reported as "NA". No further information was provided. Outcome was fatal. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.


VAERS ID: 567979 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Indiana  
Vaccinated:2014-09-26
Onset:0000-00-00
Submitted: 2015-02-26
Entered: 2015-03-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U5024CA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Chest X-ray abnormal, Death, Full blood count, Pneumonia
SMQs:, Cardiomyopathy (broad), 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: 2014-12-17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Pneumonia noted per chest x-ray; CBC, Unknown, UNK
CDC Split Type: 2015SA023267

Write-up: Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" received from the same reporter (with 8 patients identified). The other patients are captured in cases 2014SA157362, 2015SA023263, 2015SA023893, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924 and 2015SA023928. An 83 year-old male patient had received on 26 September 2014 an intramuscular left arm injection of FLUZONE HIGH DOSE (lot number U5024CA with expiration date of 12 May 2015) and "shortly after vaccination" was diagnosed with pneumonia; the patient died on 17 December 2014, approximately 3 months after vaccination. The patient had a chest x-ray on which pneumonia was noted; CBC was obtained, but results were not reported. Illness at the time of vaccination was none. Concomitant medications and pre-existing conditions were reported as "NA". No further information was provided. Outcome was fatal. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.


VAERS ID: 575996 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-23
Entered: 2015-04-29
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic shock, Death, Pharyngeal oedema
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA050399

Write-up: Initial unsolicited case received from a health care professional on 14 April 2015. A female patient (confidential), whose medical history and concomitant medications were not reported, had received a dose of Influenza Vaccine (batch number, route and site of administration were not reported) on unspecified date. On unspecified date, the patient experienced a severe reaction, swollen throat and anaphylactic shock and died while using the vaccine. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the events was fatal. Documents held by sender: None.


VAERS ID: 576026 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-04-29
Entered: 2015-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood creatinine increased, Blood pressure normal, Body temperature increased, Brain natriuretic peptide increased, Chest X-ray abnormal, Death, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram T wave inversion, Electrocardiogram normal, Endotracheal intubation, General physical health deterioration, Heart rate normal, Hypoxia, Influenza, Influenza A virus test positive, Influenza like illness, Mechanical ventilation, Polyuria, Pulmonary congestion, Rales, Respiratory alkalosis, Respiratory distress, Resuscitation, Stress cardiomyopathy, Tachycardia, Troponin increased, Vaccination failure, Ventricular arrhythmia, Ventricular hypokinesia, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: 5-Azacytidine
Current Illness: Hypertension; Hyperlipidaemia; Myelofibrosis; Acute myeloid leukaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 3 months after vaccination, nasopharyngeal swab was taken that was positive for influenza A antigen of the H3N2 strain. At admission, upon initial examination, she was noted to have important respiratory distress with laboured respiration, her temperature was 103.4 deg. F, her respiratory rate was 31 rpm and her oxygen saturation was 88% on air and 92% on a non-rebreather mask. According to the authors, her blood pressure and heart rate were within normal limits and her pulmonary auscultation was unremarkable. Her initial chest x-ray and electrocardiogram were unrevealing, but when repeated after 3 days the X-ray showed pulmonary vascular congestion and left basilar airspace disease; and the electrocardiogram showed new T-wave inversions in V3 to V6. Her cardiac troponin level was 1.949 ng/mL, creatinine was 1.3 mg/dL and brain natriuretic peptide was 2224 pg/mL. She underwent a bedside echocardiogram performed by a cardiologist that revealed a reduced left ventricular ejection fraction (30%) and severe hypokinesis of all mid to distal walls and apex.
CDC Split Type: US2015GSK057792

Write-up: This case was reported in a literature article and described the occurrence of death in a 84-year-old female patient who received Influenza vaccine. Concurrent medical conditions included hypertension, hyperlipidemia, myelofibrosis and acute myeloid leukemia. Concomitant products included 5-Azacytidine. On an unknown date, the patient received influenza vaccine (unknown). On an unknown date, 91 days after receiving influenza vaccine, the patient experienced death (serious criteria death and GSK medically significant), takotsubo cardiomyopathy, vaccination failure (serious criteria GSK medically significant), influenza (serious criteria hospitalization), respiratory distress (serious criteria hospitalization and GSK medically significant), labored respiration (serious criteria hospitalization), tachycardia, crackles lung, hypoxia (serious criteria GSK medically significant), respiratory alkalosis, ventricular arrhythmia (serious criteria GSK medically significant) and lung congestion (serious criteria GSK medically significant). The patient was treated with oseltamivir, operations and procedures (intubation), non-drug therapy (ventilation) and non-drug therapy (cardiopulmonary resuscitation). On an unknown date, the outcome of the death was fatal and the outcome of the takotsubo cardiomyopathy, vaccination failure, influenza, respiratory distress, labored respiration, tachycardia, crackles lung, hypoxia, respiratory alkalosis, ventricular arrhythmia and lung congestion were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death, takotsubo cardiomyopathy, vaccination failure, influenza, respiratory distress, labored respiration, tachycardia, crackles lung, hypoxia, respiratory alkalosis, ventricular arrhythmia and lung congestion to be related to influenza vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a vaccination failure in an 84-year-old female patient who had received unspecified seasonal influenza vaccine (manufacturer unknown). Concurrent conditions included hypertension, hyperlipidemia, myelofibrosis and associated acute myeloid leukemia. Concomitant medication included chemotherapy of which she had received the last cycle with 5-Azacytidine 3 weeks before the event. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On unspecified dates, the patient received a dose of unspecified seasonal influenza vaccine (dosage unknown; administration route unspecified; batch number not provided). On an unspecified date, approximately 3 months after the vaccination, the patient developed flu-like symptoms. She was seen at the oncology clinic 3 days later where a nasopharyngeal swab was taken that was positive for influenza A antigen of the H3N2 strain. Despite antiviral treatment, she required admission to hospital 2 days later due to respiratory distress and deterioration of the symptoms. Upon initial examination, she was noted to have important respiratory distress with laboured respiration; her temperature was 103.4 deg. F, her respiratory rate was 31 rpm and her oxygen saturation was 88% on air and 92% on an non-rebreather mask. According to the authors, her blood pressure and heart rate were within normal limits and her pulmonary auscultation was unremarkable. The patient seemed to improve with the continuation of the treatment on the following days; but 3 days after admission she required intubation and mechanical ventilation as she had become acutely short of breath, tachycardic with bibasilar crackles on auscultation, hypoxic and was noted to have respiratory alkalosis. After further examination she was first believed to have acute coronary syndrome but she was finally diagnosed with Takotsubo cardiomyopathy. However she developed a ventricular arrhythmia and she died on day 4 of hospitalisation despite aggressive medical treatment and cardiopulmonary resuscitation. This case was considered serious as it had a fatal outcome. Cause of death was unspecified, it was unknown if a post-mortem was performed. Her initial chest x-ray and electrocardiogram were unrevealing, but when repeated after 3 days the X-ray showed pulmonary vascular congestion and left basilar airspace disease; and the electrocardiogram showed new T-wave inversions in V3 to V6. Her cardiac troponin level was 1.949 ng/mL, creatinine was 1.3 mg/dL and brain natriuretic peptide was 2224 pg/mL. She underwent a bedside echocardiogram performed by a cardiologist that revealed a reduced left ventricular ejection fraction (30%) and severe hypokinesis of all mid to distal walls and apex. According to the authors, these results were suggestive of apical ballooning syndrome or Takotsubo cardiomyopathy. Initial treatment consisted of oral oseltamivir that was started at her oncology outpatient clinic. She later required intubation and mechanical ventilation, dieresis, unspecified medical management and unspecified cardiopulmonary resuscitation. The authors did not comment on any causal relationship between the events and the vaccination. The authors concluded that "Influenza A infection has rarely been linked to the development of Takotsubo cardiomyopathy. Excessive catecholamine release is believed to play a role in the pathogenesis and the treatment is largely empirical and supportive. Although Takotsubo cardiomyopathy -related mortality rates are low (1-3.2%), patients with associated severe infections such as influenza have a worse prognosis. Identifying influenza patients with higher mortality risks may allow for more favourable clinical outcomes in these patients".


VAERS ID: 609819 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-12
Entered: 2015-11-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / UNK UN / IM

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: Unknown
Current Illness: Unk
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA179107

Write-up: Initial unsolicited report received from a physician on 05 November 2015. This case was linked to 2015SA179115 and 2015SA179116 (same reporter). This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series and site of administration were not reported) intramuscularly on an unspecified date in 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were not reported. On an unspecified date in 2015, following the vaccination, the patient died. Relevant diagnostic tests/laboratory data and corrective treatment was not reported. The outcome was fatal. List of documents held by sender: none.


VAERS ID: 611827 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-26
Entered: 2015-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Adverse event, Death
SMQs:, Dementia (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:
CDC Split Type: WAES1511USA013397

Write-up: This spontaneous report was received from a physician via company representative regarding a female patient of unknown age. Patient''s concurrent condition, medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with an injection of GARDASIL 9 (lot #, expiry date and dose number was not specified) intramuscularly and FLUMIST. The patient went back to the physician''s office the same day of vaccination for an unspecified reason. The next day, she did not participate in gym class at her school for an unspecified reason and died at an unknown time. Medical attention was not sought. The cause of death was unknown. There was no information as to if autopsy was performed or not. Causality assessment was not reported. Additional information has been requested.


VAERS ID: 613593 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-12-07
Entered: 2015-12-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015US158435

Write-up: Case number PHHY2015US158435 is an initial spontaneous report received from a consumer (patient''s daughter) on 23 Nov 2015. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date, she passed away from heart failure. The reporter stated that she did not think having the influenza vaccine over the years was related to the event. No further information was provided.


VAERS ID: 617885 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-01-06
Entered: 2016-01-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Bronchial wall thickening, Chest X-ray abnormal, Circulatory collapse, Cough, Death, Extracorporeal membrane oxygenation, Haemodynamic instability, Lung consolidation, Lymphopenia, Mechanical ventilation, Nasal congestion, Neutropenia, Pneumonia bacterial, Polymerase chain reaction positive, Pyrexia, Respiratory distress, Respiratory failure, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Vasopressive therapy
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Cytarabine (NGX); Palivizumab
Current Illness: Unknown
Preexisting Conditions: Antibiotics; Mechanical ventilation, Extracorporeal mechanical oxygenation support
Allergies:
Diagnostic Lab Data: Chest X-ray, Abnormal, Significant, Left lower lobe consolidation pneumonia suggestive of secondary bacterial infection; Polymerase chain reaction, Abnormal, Significant, Respiratory syncytial virus was detected
CDC Split Type: PHHY2015US170668

Write-up: Case number PHHY2015US170668, is an initial literature case report received on 24 Dec 2015. The author in the article discussed about acute respiratory infections (ARI) in children and adolescents with acute lymphoblastic leukemia. Patients (less than or equal to 18 years) who were newly diagnosed with acute lymphoblastic leukemia (ALL) and were enrolled on an ALL treatment protocol (total therapy XVI) between Oct 2007 and May 2011 were evaluated. The total therapy XVI therapy consisted of a 6-week remission induction, 8-week consolidation and 120-week continuation phase that included two 3-week periods of more intensive chemotherapy (reinduction I and reinduction II). This report refers to an 11-month-old female patient. Past medical history and concomitant medication was not reported. The patient started therapy with cytarabine (manufacturer: not reported) for acute lymphoblastic leukemia at an unknown dose and route from an unknown date. The patient received palivizumab (manufacturer: not reported) for immunoprophylaxis at an unknown dose and route on an unknown date. The patient was vaccinated with two doses of seasonal influenza vaccine (manufacturer and batch number: not reported) on unknown dates. It was reported that 10 days before developing illness, the patient had received palivizumab. Also it was reported that on an unknown date the patient received high dose of cytarabine for reinduction II chemotherapy. The patient was presented in the hospital with a 3-day history of progressively worsening cough, nasal congestion, fever, respiratory distress with profound neutropenia and lymphopenia for which the patient was hospitalized. Initial evaluation revealed the patient had bilateral peribronchial thickening and respiratory syncytial virus (RSV) was detected on a nasopharyngeal wash specimen by polymerase chain reaction (PCR). Treatment was started with aerosolized ribavirin in addition to oxygen support and broad spectrum antibiotic therapy. However, due to progressive respiratory deterioration and increasing fever, a chest x-ray was repeated on day 5 of hospitalization which demonstrated left lower lobe consolidation pneumonia suggestive of secondary bacterial infection. The patient''s treatment regimen included vancomycin, meropenem, azithromycin, voriconazole, palivizumab and aerosolized ribavirin. On day 28 of hospitalization, the patient experienced respiratory and hemodynamic failure which required mechanical ventilation and vasopressor followed by extracorporeal mechanical oxygenation support. The patient died 2 months after onset of the RSV infection. The outcome of events respiratory syncytial virus infection, respiratory failure, circulatory failure and pneumonia bacterial was fatal and outcome of events lymphopenia and neutropenia was not reported. Action taken with palivizumab and cytarabine was unknown. The author stated that despite the low incidence of viral ARI in children with ALL, the associated morbidity, mortality and delay in chemotherapy remain clinically significant. Viral lower respiratory tract infection was especially associated with high morbidity requiring intensive care-level support. The author concluded that in spite of current advances in ALL cure rates, molecular diagnostic techniques, antiviral therapies and active and passive immune prevention approaches, respiratory viral infections remain a significant burden in children with ALL.


VAERS ID: 618812 (history)  
Form: Version 1.0  
Age: 0.74  
Sex: Female  
Location: Ohio  
Vaccinated:2015-12-16
Onset:0000-00-00
Submitted: 2016-01-13
Entered: 2016-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U5387DB / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-18
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: No illness or disease
Preexisting Conditions: No preexisting conditions; Full term birth - uneventful
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received flu vaccine on 12-16-15 at a well child 9 month check. Patient had no preexisting conditions, no adverse reaction. Patient died on 12-18-15 from unknown causes pending autopsy/coroner report. No adverse reaction occurred prior to death.


VAERS ID: 623311 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-22
Entered: 2016-02-22
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: PHHY2016US023178

Write-up: literature case report received on 18 Feb 2016. The author in the article discussed about membranous nephropathy (MN) and severe acute kidney injury (AKI) following influenza vaccination. This report refers to a male patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after receiving vaccination, the patient died from GB syndrome. It was unknown if an autopsy was performed. The author presented an interesting case of MN and severe AKI following the 2009 H1N1 vaccination (see case: PHHY2016US023093). Optimal therapy of influenza vaccine associated glomerular diseases including MN was unknown. The author concluded that based on the experience one can consider corticosteroid therapy in patients with MN and AIN following influenza vaccination. However, further studies are required to investigate the exact pathogenesis of influenza vaccine-induced MN.


VAERS ID: 625003 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-27
Entered: 2016-03-03
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Adrenal atrophy, Air embolism, Anaphylactic shock, Autopsy, Body temperature increased, Cheyne-Stokes respiration, Chills, Cyanosis, Death, Ecchymosis, Emphysema, Eosinophil percentage, Epistaxis, Haemoglobin, Heart rate increased, Hypersensitivity, Hyperthermia, Injection site haemorrhage, Lymphocyte percentage increased, Mechanical ventilation, Mouth haemorrhage, Muscle contractions involuntary, Muscle spasms, Muscle twitching, Mydriasis, Neutrophil percentage decreased, Pericardial haemorrhage, Pulmonary congestion, Pulse abnormal, Puncture site haemorrhage, Pupillary light reflex tests abnormal, Rales, Red blood cell count normal, Respiratory arrest, Seizure, Shock, Staphylococcus test positive, Streptococcus test positive, Vaccination complication, Vaginal haemorrhage, Vein collapse, Vomiting, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Agranulocytosis (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (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), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (narrow), Retinal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Acetylsalicylic acid; Drug reaction: Urticaria, For one day during the first year of life
Allergies:
Diagnostic Lab Data: Body temperature, 103 Fahrenheit, Significant; Body temperature, 109 Fahrenheit, Significant; Culture, Abnormal, Grew a streptococcus of the alpha group and Staphylococcus aureus; Eosinophil count, 3 %, Significant; Haemoglobin, 82.2 %, Significant; Haemoglobin, 80 %, Significant; Heart rate, 180/min, Significant; Heart rate, 240/min, Significant; Lymphocyte count, 61 %, Significant; Lymphocyte count, 74 %, Significant; Neutrophil count, 26 %, Significant; Neutrophil count, 36 %, Significant; Red blood cell count, 4.02 million red cells, Significant; Red blood cell count, 4.75 million red cells, Significant; White blood cell count, 7,400, Significant; White blood cell count, 44,000, Significant
CDC Split Type: PHHY2016US023690

Write-up: Case number PHHY2016US023690, is an initial literature case report received on 22 Feb 2016. The author discussed about the fatal allergic reaction due to influenza vaccine. This report refers to a 42-month-old female patient. Past drug history included acetylsalicylic acid and the patient experienced hives for one day during the first year of life which were thought to follow medication. There was no history of asthma and no family history indicative of allergy could be elicited. Prior to the injection of the vaccine the physician had attempted to obtain a history of allergy to eggs or chicken with negative results. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) subcutaneously at a dose of 0.5 ml on an unknown date. The patient complained of pains in the abdomen and chills followed by vomiting and convulsions four hours after the vaccination. On examination the patient had a rectal temperature of 109 F. The patient was hospitalized within two hours after the onset of symptoms. On admission to the hospital the patient showed pronounced cyanosis, pupils were widely dilated and unresponsive to light. The lungs showed moist rales over both pulmonary fields and the heart rate was 180 per minute. The abdomen was not distended. The extremities showed convulsive contractions during examination. During the seven hour stay in the hospital the patient became increasingly cyanotic despite oxygen and epinephrine hydrochloride therapy. It was noted that bleeding was pronounced at the sites of hypodermic puncture for the administration of medicaments and that large areas of ecchymosis developed around the injected sites. Slight bleeding was also noted from the vaginal and oral orifices. Convulsions occurred at one to two minute intervals. The convulsions ceased after about five hours and the temperature fell to 103 F. The heart rate increased in rapidity up to 240 per minute but remained regular. The respirations were noted to be Cheyne-Stokes in type. Two hours after entry to the hospital breathing ceased and artificial respiration was instituted. After the resumption of respiration constant bilateral twitching and spasms were noted. This was most decided in the lower extremities. Five hours after admission and seven hours after the onset of symptoms the patient showed great shock with pronounced collapse of the veins which rendered venipuncture difficult. Thirty minutes before death a surgical exposure of the right ankle vein was considered necessary for intravenous therapy. At that time an attempt was made to administer dextrose and saline solution with 10 per cent calcium gluconate. The patient was becoming more cyanotic and it was difficult to obtain the pulse beat. Artificial respiration was again instituted and after an intracardiac injection of epinephrine hydrochloride the patient was pronounced dead. Blood examination showed 80 per cent hemoglobin, 4.02 million red cells and 44,000 white cells with 36 per cent neutrophils, 61 per cent lymphocytes and 3 per cent eosinophils. The clinical picture of the patient was that of an allergic reaction which developed four hours after the injection and was characterized by convulsions, abdominal pain and vomiting with associated hemorrhagic phenomena., respiratory arrest, hyperthermia and death. The outcome of the event convulsions was recovered and outcome of other events was not reported. The cause of death was ascribed to anaphylactic shock secondary to the injection of influenza vaccine with air embolism as an immediate terminal contributory cause. A necropsy was performed about eleven hours after death which revealed the following: Heart: Air embolism was present in the right side of the heart and in the inferior vena cava; there were multiple epicardial hemorrhages. Thymus: Petechial subcapsular hemorrhages were present. Lungs: There were bilateral hypostatic congestion, emphysema of the right middle lobe and focal intra-alveolar hemorrhage. Adrenal: Decided bilateral atrophy was observed. Gastrointestinal Tract: Submucosal petechial hemorrhage of the esophagus was seen. Genitourinary Tract: There were submucosal petechial hemorrhages of the vagina. General: Multiple puncture wounds of the upper extremities and a recent phlebotomy wound of the right lower extremity were observed. Gross Observations: The body was that of the patient about 3 years of age and of normal height and weight. The left nostril showed abundant dried, blood tinged, foamy material. On the arms there were multiple hypodermic puncture marks in the region of the deltoid insertion on either side and small drops of fluid blood could be readily squeezed from the puncture wounds. The contiguous skin was ecchymotic. The left inguinal region showed recent venipuncture wounds with adjacent ecchymoses. The right longer extremity showed the presence of a recent transverse incision of the skin placed on the medial surface of the ankle and held together by interrupted sutures. The vagina showed the presence of two zones of submucosal hemorrhage just inside the fourchet. On incision of the fit it was noticed that the cut ends of the capillaries oozed fluid blood. When the thorax was opened both lungs lay free in the pleural sacs and did not appear hyperventilated. The right ventricle was greatly dilated and though its partly transparent wall multiple bubbles of air mixed with blood could be readily seen. With the circulation intact, several of the large venous pathways to the heart were exposed. The superior vena cava was natural. The left subclavian vain showed no evidence of air in its lumen. The inferior vena cava exposed along its entire length was seen to be distended and rounded and to contain a continuous column of frothy fluid blood along its entire length. The femoral vessels were exposed on both sides. Both femoral veins were collapsed. When the vessels were milked in a direction from the periphery to the trunk air bubbles were not recognized in either vessel; on milking the right iliac vein from the inguinal region in a cephalad direction, bubbles of air mixed with blood were seen. On exploration of the incised cutaneous wound of the right ankle at the site of phlebotomy, the underlying vein was readily identified and showed a ligature around its wall. Just proximal to the ligature a small nick corresponding to the site of puncture was readily identified. Anatomic Observations: Heart: The heart on removal weighed 909 Gm. The epicardial surfaces showed extensive Flame shaped hemorrhages both anteriorly and posteriorly. The right auricle and ventricle contained abundant fluid blood intimately mixed with numerous air bubbles of various sizes. The remainder of the examination of the heart revealed essentially normal structure. Lungs: The right lung weighed 120 Gm., the left 130 Gm. The posterior portions of both lobes of the left lung were dark red and on section cut with somewhat increased resistance to reveal a glistening, dark red, homogenous, nonconsolidated tissue, sections of which sank readily in water. The anterior portions of both lobes on this side were air containing and moderately congested and showed, in addition, scattered areas of circumscribed recent intra alveolar hemorrhage. The bronchi on this side showed intensely engorged mucosal surfaces having the appearance of red velvet. A culture taken from the main bronchus on this time grew a streptococcus of the alpha group and Staphylococcus aureus. The right lung had four lobes. The two lower lobes showed dark red circumscribed areas on their posterior portions, resembling those seen on the left side. In addition occasional lobules in the upper lobe appeared to be partly collapsed, being distinctly depressed below the adjacent pleural surfaces. One of the lobes also had a local area of emphysema on its anterior margin. The bronchi on this side resembled those of the left. The hilar nodes were natural. Thymus: The thymus was enlarged, weighed 30 Gm. and showed multiple subcapsular petechial hemorrhages. The cut surface was not noteworthy. Liver: The liver weighed 420 Gm. On section it revealed indistinctness of the lobular markings, the larger vessels oozing abundant blood. Spleen: The spleen weighed 55 Gm. and on section showed follicular hyperplasia. The pulp was firm and dark red. Adrenals: The adrenals were decidedly atrophic in appearance, the cortices being about 1 mm. in thickness. The medulla was similarly totally reduced on the side. Kidneys: The right kidney and left kidney each weighed 45 Gm. On section the cut surfaces were engorged. Uterus and Adnexa: The uterus and adnexa were natural for the age. Gastrointestinal Tract: The esophagus presented a few small submucosal hemorrhages in the distal half. The stomach contained about 2 ounces (59 cc.) of dark mucoid coagulum and showed normal mucosal surfaces. Lymphoid tissue: The Lymphoid tissues in the normal sites, more especially in the mesentery, were discretely enlarged and showed congested homogenous cut surfaces. Brain: The brain weighed 1,360 Gm and showed greatly engorged cerebral surfaces. On section the capillary systems in the gray and white matter were appreciably engorged. Microscopic examination showed sections of the lungs early acute interstitial inflammation in which mononuclear cells with fewer polymorphonuclear and only occasional eosinophils were seen. There was well defined intra alveolar and subpleural edema. In addition many of the air spaces showed recent intra-alveolar extravasation of red cells. Many colonies of bacteria were noted in the alveoli and bronchioles and were entirely devoid of any adjacent inflammatory cellular reaction. Occasional bronchioles showed the presence of their lumens of acidophilic albuminous exudate mixed with red cells. Sections of the heart muscle showed decided congestion of the vessels with scant areas of recent interstitial hemorrhage. There was well defined interstitial and subendocardial edema present. Sections of the spleen and lymph nodes displayed early follicular necrosis. The spleen on careful search failed to reveal any eosinophilic cells. The sections of the lymph node showed moderate eosinophilic cell infiltration. The adrenals manifested well defined cortical and medullary atrophy. The remainder of the organs revealed acute congestive change. The post mortem examination of the blood revealed 82.2 per cent hemoglobin, 4.75 million red cells and 7,400 white cells, with 26 per cent neutrophils, 74 per cent lymphocytes and a 0.87 color index. The author stated the fatal case of severe hemorrhagic allergic reaction occurred in the patient after influenza A and B vaccine was given subcutaneously in the prescribed dose. It was recommended that attempts should be made to further purify the various virus vaccines now becoming generally used so as to materially diminish the amount of reacting egg substances in the mediums of the marketed product. Since children appear more sensitive to egg protein than do adults greater precautions should be taken in this group of patients in the course of immunization with vaccines grown on egg mediums. The author concluded that simple precautions which have been outlined are observed should be little or no danger in continuing the vaccination of the civilian population with these agents which the accumulated evidence showed to have definite immunization value.


VAERS ID: 625642 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-07
Entered: 2016-03-07
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, 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: USBEH2016059464

Write-up: This medically confirmed literature report (initial receipt 23-Feb-2016) concerns a male patient. On an unknown date, the patient received an influenza vaccine (brand, batch number and route unspecified) for indication not provided. On an unknown date following vaccination, the patient developed GB syndrome from which he died. The outcome was reported as fatal. Linked to case: 2016059460 (same reporter). Reporter''s Comments: Reporter comments: n/a. Sender''s Comments: Company''s evaluation and comment: Seriousness criterion/criteria: Fatal outcome. Listedness: Unlisted. Brand of Influenza vaccine not provided. Assessment according to the CSL Inactivated Influenza Virus Vaccine CCDS and the Afluria Product Information, GBS is unlisted due to the fatal outcome. Company Causality: Unassessable. Temporal relationship could not be established. GBS is a known class effect of Influenza vaccine in general and is mediated by immune attack on peripheral nerve myelin. Risk factors include upper respiratory, infections, (40% of cases) and or preceding diarrheal illness due to campylobacter infection (20%). The outcome is usually complete recovery over weeks to months however fatal outcome is due to autonomic disturbances resulting in cardiac arrest being the most common cause, in 20-30% of deaths. Due to missing information causality is unassessable.


VAERS ID: 629846 (history)  
Form: Version 1.0  
Age: 0.11  
Sex: Female  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-29
Entered: 2016-03-30
   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: Bacterial infection, Bronchial wall thickening, Chemotherapy, Chest X-ray abnormal, Circulatory collapse, Cough, Death, Extracorporeal membrane oxygenation, Lymphopenia, Mechanical ventilation, Nasal congestion, Neutropenia, Pneumonia, Polymerase chain reaction positive, Pyrexia, Respiratory distress, Respiratory failure, Respiratory syncytial virus infection
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Medicinal Product Name as Reported by the Primary Source: Cytarabine
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute lymphocytic leukaemia (Acute lymphoblastic leukemia)
Allergies:
Diagnostic Lab Data: Test Name: Nasopharyngeal wash specimen; Result Unstructured Data: bilateral peribronchial; Test Name: Chest x-ray; Result Unstructured Data: Left lower lobe consolidation pneumonia
CDC Split Type: USBEH2016060509

Write-up: This medically confirmed literature report (initial receipt 15-Mar-2016) concerns an 11 months old female patient who had a medical history of acute lymphoblastic leukemia (ALL) and received a high dose of cytarabine for reinduction II chemotherapy. She presented with a 3 day history of progressively worsening cough and nasal congestion and new onset of fever and respiratory distress with profound neutropenia and lymphopenia for which she was hospitalised. She had received palivizumab immunoprophylaxis 10 days before the development of her illness and 2 doses of seasonal influenza vaccine. Initial evaluation revealed bilateral peribronchial thickening and RSV (respiratory syncytial virus) was detected on a nasopharyngeal wash specimen by PCR. Aerosolized ribavirin treatment was initiated in addition to oxygen support and broad spectrum antibiotic therapy. However, due to progressive respiratory deterioration and increasing fever, a chest x-ray repeated on day 5 of hospitalization demonstrated left lower lobe consolidation pneumonia suggestive of secondary bacterial infection. Her treatment regimen included vancomycin, meropenem, azithromycin, voriconazole, palivizumab, and aerosolized ribavirin. On hospital day 28, her condition progressed to respiratory and hemodynamic failure requiring mechanical ventilation and vasopressor followed by extracorporeal mechanical oxygenation support. She died 2 months after onset of the RSV infection. The outcome was fatal. Reporter''s Comments: n/a. Sender''s Comments: Company comments: Seriousness: Serious. Fatal Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the agency for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information all events are unlisted except pyrexia, nasal congestion, and cough. Causality: Unassessable. The events pertaining to inappropriate age at vaccine administration is unassessable. For all other events, it is unrelated. The reports pertains to a pediatric patient undergoing chemotherapy who developed various respiratory symptoms. Further investigation revealed that causative agents were RSV and a bacterial pathogen. Patient has also received chemotherapy which can cause neutropenia and lymphopenia. In the clear presence of laboratory demonstration of offending causal agents, and a known recent history of leukemia and chemotherapeutic treatments, the reported systemic symptoms, respiratory events, and hematologic parameters are considered unrelated to influenza vaccine.


VAERS ID: 634569 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: California  
Vaccinated:2015-09-02
Onset:0000-00-00
Submitted: 2016-05-06
Entered: 2016-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Fatigue, Influenza, Pain
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: USSA2015SA204766

Write-up: Based on the additional information received on 07 March 2016, this case initially considered as non-serious was upgraded to serious due to death of the patient. Initial unsolicited report received from a physician on 03 December 2015. This case involves a male patient (age unknown) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route, dose in series and site of administration were not reported) on 2 September 2015. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced flu symptoms, exhaustion and body ache. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none. Follow up information received from Physician on 07 March 2016. It was reported that, patient''s details could not be obtained as patient died (details not provided) on an unspecified date. Sender''s Comments: Initial case, reported events was flu symptoms, exhaustion and body ache with patient has since Deceased (from other reason)" date was not reported and in follow-up reported that patient has since Deceased (from other reason)" date was not reported. limited information was provided in document. Additional information on patient''s medical history and concomitant medications, health status at vaccination, final diagnosis and complementary investigations ruling out alternative etiology and autopsy report are needed for complete assessment. Based on available information, role of vaccine cannot be established. Reported Cause(s) of Death: death nos.


VAERS ID: 639404 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-14
Entered: 2016-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN
HPVX: HPV (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1606USA006441

Write-up: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. There was no information about the patient''s concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of HPV vaccine (manufacturer unknown) (dose, strength, route of administration, lot# and expiry date were not reported) and a dose of FLUMIST (dose, strength, route of administration, lot# and expiry date were not reported). It was reported that the patient went back to the physician office the same day of vaccination for an unspecified reason. The next day (date unspecified), the patient died. Cause of death was not reported. The causality between the suspect vaccines and the patient''s death was not reported. Upon internal review the event was considered to be medically significant. This is one of several reports received from the same source. Additional information is not expected as there was no contact details provided.


VAERS ID: 648868 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-08-23
Entered: 2016-08-23
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: 2016-04-01
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: Alirocumab prefilled pen
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA066470

Write-up: Initial information regarding this clinically sponsored solicited case was received on 28-Mar-2016 from patient''s wife via the Patient Support Program. This case concerns a male patient of unknown age who had multitude of health issues, COPD and he came down with influenza B an unknown duration after commencing treatment with influenza vaccine and PRALUENT. No information on any past drug, concomitant drug, medical history or concurrent condition was reported. On an unknown date, the patient commenced treatment with influenza vaccine (dose, form, route, frequency, lot/batch number and expiration date: unknown). On an unknown date, the patient received alirocumab injection at a dose of 75 mg every other week subcutaneously (lot/batch number and expiry date unspecified) for other and unspecified hyperlipidemia delivered via prefilled pen. Patient''s wife reported that the patient took the flu shot and came down with influenza B on an unknown date (latency: unspecified), because the patient had COPD (date and latency: unknown) so he was placed in the hospital. The patient was taking TAMIFLU as corrective treatment and was getting better. The reporter informed that the patient expired in April and that he had a multitude of health issues (onset and latency: unspecified). It was unknown whether an autopsy was done or not. It was reported that the patient had two injections up to that point. Action taken: Unknown for both the drugs. Outcome: fatal for multitude of health issues, Recovering for other events. Seriousness criteria: Hospitalization, patient died from multitude of health issues. Reporter causality: Unknown with respect to alirocumab and not reported with respect to influenza vaccine for multitude of health issues and unknown for both the drugs for other events. Company causality: Not associated with respect to both the drugs. Additional information was received on 23-May-2016 from patient''s wife: new event "multitude of health issues" added, action taken updated, form of alirocumab added and text updated accordingly. Reported Cause(s) of Death: multitude of health issues.


VAERS ID: 655573 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-09-26
Entered: 2016-09-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2016GSK139073

Write-up: This case was reported by a consumer and described the occurrence of unknown cause of death in a 70-year-old female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The patient was the relative of the reporter. The patient received the vaccine and died on an unknown date due to an unknown cause. The autopsy details were not provided. Due to the patient''s death after taking the FLULAVAL vaccine, the reporter was afraid to get the vaccine.


VAERS ID: 658633 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Mississippi  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-10-12
Entered: 2016-10-12
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, Lung neoplasm malignant
SMQs:, Non-haematological malignant tumours (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2016SA184645

Write-up: Initial unsolicited report received from a consumer via other company (Pfizer) on 03-Oct-2016. Manufacturer Report Number: 2016444837. This case involves a female patient (age not reported) who was vaccinated with FLU SHOT (manufacturer: unknown) (batch number, expiry date reported as unknown, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient''s medical history and Concomitant medications were not reported (reported as none provided). On an unknown date, following the vaccination, the patient got a touch of the flu and lung cancer. The patient''s laboratory data (reported as none provided) and corrective treatment was not reported. The outcome of event: flu was not reported. It was reported that patient died 11-year ago and cause of death was lung cancer. List of documents held by sender: none. Sender''s Comments: This is poorly documented consumer case where influenza was reported after administration of influenza vaccine and patient died due to lung cancer. However detail autopsy report, date of death, onset of lung cancer and administration date would be helpful to assess this case further. According to provided information no conclusion can be drawn. Reported Cause(s) of Death: lung cancer.


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