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Found 8,467 cases where Patient Died

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VAERS ID: 552518 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-24
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011532

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552519 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-24
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011535

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552520 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-24
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011531

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552521 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-24
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011533

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552522 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-24
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011534

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552531 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-24
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011529

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552532 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-24
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011526

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552533 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-24
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011525

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552537 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-24
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011522

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552539 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-24
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011527

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552540 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-24
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011524

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552541 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-24
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011523

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information not expected.


VAERS ID: 552619 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-24
Entered: 2014-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011521

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. 23-Oct-2014: The reporter has not further information regarding the patients. Additional information is not expected.


VAERS ID: 553330 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2014-07-30
Onset:2014-07-30
   Days after vaccination:0
Submitted: 2014-10-29
   Days after onset:91
Entered: 2014-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Death, Endotracheal intubation, Irritability, Nasopharyngitis, Sudden infant death syndrome
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (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: 2014-08-02
   Days after onset: 3
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: 07/30/2014, Body temperature, mild temperature and cold
CDC Split Type: WAES1410AUS014248

Write-up: Information has been received from bioCSL on 27-OCT-2014. This spontaneous report as received from a consumer who is the patient''s mother refers to a 6 month and 9 days old female patient. Medical history and concurrent conditions were not reported. On 30-JUL-2014 at 9:30am, the patient was vaccinated with ROTATEQ does 3. Other suspect therapies included INFANRIX HEXA dose 3, and PREVENAR 13 dose 3. Dose, route, lot number and expiration date were not reported for any suspect drug. The patient''s mother reported that patient was unwell on day of immunisations with mild temperature and cold (on 30-JUL-2014). The mother discovered the patient at 22:30 hrs under bedsheets in maternal bed nor breathing and looking strange. She contacted emergency services and commenced resuscitative measures (on 02-AUG-2014). Mother stated that patient was fussy since immunisation (on 20-JUL-2014) but no other signs of acute medical illness. Emergency services arrived and continued CPR with intubation, intraosseous fluid administration of adrenaline, bicarbonate and normal saline. CPR ceased at 23:25 hrs. Patient declared dead and taken to hospital. Presented to emergency department with ambulance service, dead on arrival. Patient passed away on 02-AUG-2014. Cause of death was sudden infant death syndrome. Autopsy results was not reported. The outcome of mild temperature and cold was unknown. Upon internal review the event intubation was considered as an other important medical events. Additional information is expected.


VAERS ID: 553974 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-10-24
Onset:2014-10-25
   Days after vaccination:1
Submitted: 2014-10-31
   Days after onset:6
Entered: 2014-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Autopsy, Death, Malaise, Vomiting
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-25
   Days after onset: 0
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: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On 25-OCT-2014 (12:59): vascular access portfolio was performed.
CDC Split Type: WAES1410JPN015556

Write-up: Initial information has been received from a pharmacist concerning a 79 years old female patient with a history of hypertension who on 24-OCT-2014 was vaccinated with PNEUMOVAX NP (dose, lot number, indication not reported) (route reported as parenteral). Other concomitant medication was Influenza HA vaccine (manufacturer unknown) (daily dosage, indication unknown). On 24-OCT-2014, the patient was vaccinated with PNEUMOVAX NP and Influenza HA vaccine (manufacturer unknown) at same time at hospital A. The patient felt physical deconditioning at night fall. On 25-OCT-2014, the patient developed vomiting and general malaise. The patient was transported to the reporter''s hospital by an ambulance. At 12:59, the vascular access portfolio was performed. The patient died at 14:00. The cause of death and the information of autopsy were not reported. At the time of this report, the outcome of physical deconditioning, vomiting and general malaise was unknown. The reporting pharmacist did not assess the seriousness of the physical deconditioning, vomiting and general malaise. The reporting pharmacist did not assess the relationship between death, physical deconditioning, vomiting, general malaise and PNEUMOVAX NP. Additional information has been requested.


VAERS ID: 554152 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-31
Entered: 2014-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: WAES1410CAN011564

Write-up: This spontaneous report as received from a nurse via a company sales representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. No co-suspect or concomitant therapies reported. The nurse recently attended a conference on vaccinations in general. The physician who presented information on various vaccinations mentioned that there was 72 young girls who were vaccinated with GARDASIL and died due to thrombosis following vaccination (death). The outcome of death due to thrombosis following vaccination was reported as fatal. The cause of death was reported as thrombosis. The reporter considered death due to thrombosis following vaccination to be related to GARDASIL. Additional information was requested. The reporter has not further information regarding the patients.


VAERS ID: 554995 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2014-10-20
Onset:2014-10-21
   Days after vaccination:1
Submitted: 2014-10-31
   Days after onset:10
Entered: 2014-11-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER 4K07B / 2 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR K1122 / 3 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 13K03A / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aspiration, Cardio-respiratory arrest, Convulsion, Death, Heart rate decreased, Pyrexia, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Neonatal asphyxia; Hypoxic-ischaemic encephalopathy
Allergies:
Diagnostic Lab Data: Body temperature, 22OCT2014, 41.7 degree C
CDC Split Type: 2014SA148347

Write-up: Initial report received from a health authority (reference number- V14000475) via a physician on 27 Oct 2014. A 04-month-old male patient had received a subcutaneous 0.5 ml third dose of ACTHIB (batch number- K1122, anatomical site of administration were not reported) on 20 Oct 2014 at 11:00, had received a second dose of DTP-IPV (Manufacturer- Other, batch number- 4K07B route and anatomical site of administration were not reported) on 20 Oct 2014 at 11:00 and had received a third dose of PREVENAR 13 (Manufacturer-other, batch number- 13K03A, route and anatomical site of administration were not reported) 20 Oct 2014 at 11:00 hours. The patient birth weight reported as 2055 g and body temperature before vaccination was 36.5 degree C. The patient remarkable history was reported as the patient was born by perimortem Caesarean section due to road traffic accident, and had hypoxic-ischaemic encephalopathy due to severe neonatal asphyxia. On 20 Oct 2014 i.e. same day after vaccination, patient was asymptomatic on the day and on 21 Oct 2014 increased secretion was observed, and was treated with frequent oral and nasal aspirations. As he had no swallowing reflex, he usually required aspiration. On 22-Oct-2014, in the morning, patient had pyrexia of 41.7 degree C. Patient frequently had convulsion since before, and a convulsion stopped with the use of anticonvulsive suppository and the pyrexia resolved with cooling, but recurred at midnight. On 23-Oct-2014, at 01:40 a.m., patient heart rate decreased and went into cardio-respiratory arrest. Patient did not respond to resuscitation, and confirmed dead at 03:22 and the cause of the death was considered as aspiration. Reporting physician''s comment: A possible causative factor for the event was hypoxic-ischaemic encephalopathy. The event was not considered related to the vaccination. Documents held by sender: none.


VAERS ID: 555140 (history)  
Form: Version 1.0  
Age: 1.7  
Sex: Male  
Location: Foreign  
Vaccinated:2014-08-07
Onset:2014-08-10
   Days after vaccination:3
Submitted: 2014-10-31
   Days after onset:82
Entered: 2014-11-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR L4010 / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H65365 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anuria, Circulatory collapse, Death, Diarrhoea, Sepsis, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Retroperitoneal fibrosis (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), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-08-17
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014297694

Write-up: This is a spontaneous report from a contactable physician received from the regulatory authority, regulatory authority report number HU-OGYI-115014. This pharmacist reported to Health Authority on 13Oct2014 that a 20-month-old male patient of unspecified ethnicity received on 07Aug2014 at 14:57 PENTAXIM (Sanofi Pasteur SA, lot number L4010-1, exp. date unknown) at 0.5 ml single dose and PREVENAR 13 (lot number H65365, exp. date unknown) at 0.5 ml single dose. Concomitant medications were none. Medical history was unknown. As reported by the patients mother, three day later, on 10Aug2014 around 15:00, the patient experienced loose stool. On 14Aug2014 viral infection was suspected, thus the patient received ENTEROL dose and other details not provided and NORMAFLORE no further details reported. On 16Aug2014 the patient developed anuria, sepsis and circulatory failure, and was hospitalized. On 17Aug2014 the patient died. The cause of death was not reported, the treatments applied at the hospital as well as the outcome of the other adverse events were not reported. At the time of the vaccination the patient was under no medical treatment for any conditions, and the reporter has no information on whether the patient had any adverse events following previous vaccinations (no information available on the actual performance of previous vaccinations, either). Autopsy results for further information were not available at the time of the report. The investigation of the case is ongoing by the agency. No follow-up attempts needed. No further information expected.


VAERS ID: 555281 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-31
Entered: 2014-11-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumococcal sepsis, Pneumonia pneumococcal, Tonsillitis
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014296586

Write-up: This is a spontaneous report from a contactable consumer (patient grandmother). A 2 year old male patient of an unspecified ethnicity received PREVENAR 13 on unspecified date at single dose. The patient''s medical history and concomitant medications were not reported. It was reported that the patient became poorly with tonsillitis on an unspecified date and within the course of 4 days, had to be rushed to hospital on 16Oct2014. The patient had been eating as usual on Thursday 16Oct2014 having had his favourite supper of sausage and beans. On 17Oct2014 morning, he proceeded to watch cartoons on the television but then began to rapidly deteriorate the same day around lunch time. The treating physicians believed that the patient had a virus which had caused pneumonia and septicaemia. Despite multi-hospital specialist teams battling to save the patient, the patient died on that Friday 17Oct2014 at 08:35 pm. It was not reported if an autopsy was performed. It was however confirmed the patient had died from streptococcus pneumoniae (reported as Strep Pneumoni) - serotype was not specified.


VAERS ID: 556938 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-11-01
Submitted: 2014-11-07
   Days after onset:736
Entered: 2014-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Intussusception, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: ROTATEQ, First and second doses of ROTATEQ on unspecified dates. Tolerance not reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1411FRA002170

Write-up: Information has been received from SANOFI PASTEUR MSD (SPM) (manufacture control # E2014-10320) on 05-NOV-2014. Case received from two paediatricians on 31-Oct-2014 and linked to serious case E2014-10321 (same reporter, same vaccine, patients were brothers). An infant male patient had received the third dose of ROTATEQ (batch number not reported) on an unspecified date. In Nov-2012, at the age of 6 months old, he died from an undiagnosed atypical subacute intussusception. The symptoms were atypical and occurred abruptly. The patient vomited and was febrile. He died in his bed 36 hours after the first signs. The diagnosis of intussusception was determined by the autopsy. According to the paediatrician, the mother had called the emergency medical service for the symptoms that her child presented with (no further details). The physician had reportedly been reassuring. The symptoms persisted so after 2 to 3 days the mother went to the Emergency Unit Care. Intussusception was diagnosed but it was too late for an effective management of the events. To be noted that the patient was born from a different father than the patient of case E2014-10321. The tolerance of the first and second doses of ROTATEQ were not known.


VAERS ID: 558014 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2014-10-22
Onset:2014-10-24
   Days after vaccination:2
Submitted: 2014-11-17
   Days after onset:24
Entered: 2014-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 LL / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Cardiac failure, Condition aggravated, Death, General physical health deterioration, Intensive care, Resuscitation
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-24
   Days after onset: 0
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: Hospitalisation; Congenital aortic anomaly; Cardiac disorder; General physical condition abnormal; Chylothorax; Ventricular septal defect; Prophylaxis; Oedema peripheral; Atrial septal defect
Preexisting Conditions: Arterial repair; Ventricular septal defect repair; Atrial septal defect repair
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1411AUS004963

Write-up: This spontaneous report as received from a nurse via the pharmaceutical company Pfizer (other company number #2014310378) refers to a 54 day old male infant patient. The infant had an underlying medical condition of atrial septal defect (ASD)/ ventricular septal defect (VSD)/ arch repair which was complicated post operation. He had continued to have life threatening cardiac disease and chylothorax despite medical management. The patient was in the intensive care unit and was significantly unstable. The infant had extremely oedematous legs. The ward nurses were concerned about any adverse event following immunization (AEFI) but medical staff decided that the vaccines could be given. On 22-OCT-2014, the patient was vaccinated with the first dose of ROTATEQ, route default to oral, (strength, dose and lot# not reported). Other suspect therapies included the first dose of PREVENAR 13 (strength, route, dose and lot# not reported) and the first dose of INFANRIX HEXA (strength, route, dose and lot# not reported) which were vaccinated on the same day. The nurse reported that the INFANRIX HEXA was given first and the infant did not deteriorate at that time. The PREVENAR 13 was then given into the left thigh and almost immediately the patient deteriorated, with the Intensive Care Unit (ICU) nurses telling the nurse to ''get out of the way'' and the bag and mask equipment was obtained by them. It was ROTATEQ given before or after PREVENAR 13. The patient required some nursing intervention with supportive therapy of oxygen and increased observation. The nurse stated that the patient appeared to recover and the nurse immediately left the patient room and the nurse was concerned about the stability of this infant and deliberately checked the next day to ensure that the infant was still doing well. Two days after the vaccines, the nurse discovered the patient had passed away on 24-OCT-2014. The cause of death was not specified. On 24-OCT-2014, the patient also experienced cardiac failure. The outcome of cardiac failure was not reported. The reporter considered the events to be possibly related to ROTATEQ, PREVENAR 13 and INFANRIX HEXA. Upon internal review, cardiac failure and deteriorated condition were considered to be medically significant. Additional information is not expected since no reporter contact information was provided.


VAERS ID: 558765 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Male  
Location: Foreign  
Vaccinated:2014-10-22
Onset:0000-00-00
Submitted: 2014-11-17
Entered: 2014-11-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 LL / SYR
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, General physical health deterioration, Intensive care
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: 2014, to ongoing, Oedema legs; 2014 to ongoing, Cardiac aneurysm; 2014 to ongoing, VSD (Ventricular septal defect); 2014 to ongoing, Cardiac disorder; 2014 to ongoing, Chylothorax; 2014, Arch repair surgery, Aortic surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014310378

Write-up: This is a spontaneous report from a contactable nurse. Additional information included GSK manufacturer control number AU2014AUS007 and MSD manufacturer control number AUS/14/3163. An infant male patient (below 2 months of age) of unspecified ethnicity on 22Oct2014 received first dose of PREVENAR 13 at single dose in left thigh, first dose of INFANRIX HEXA and first dose of ROTATEQ, all via an unspecified route of administration at the age of 7-weeks. The patient medical history included extremely oedematous legs, aneurysm of the sinus of Valsalva (ASD), ventricular septal defect (VSD) and arch repair surgery which was complicated postoperative, life threatening cardiac disease and chylothorax. The patient''s concomitant medications were not reported. The nurse reported that the patient experienced death post routine two-month vaccination with INFANRIX HEXA, PREVENAR 13 and rotavirus vaccine. Reaction was described as follows: this patient was in the Intensive Care unit and was significantly unstable. The ward nurses were concerned about any adverse event following injection but medical staff decided that the vaccines would be given. The infant had extremely oedematous legs. INFANRIX HEXA was given first and the infant did not deteriorate at that time. PREVENAR 13 was then given into the left thigh and almost immediately the patient deteriorated, with the intensive care unit nurses that told to the reporting nurse to get out of the way and the bag and mask equipment was obtained by them. The patient appeared to recover and the reporting nurse immediately left the patient room. The nurse was concerned about the stability of this infant and deliberately checked the next day to ensure that the infant was still doing well. Two days after the vaccines, the nurse discovered the patient had passed away. This infant had an underlying medical condition ASD, VSD and arch repair which was complicated post-operative. He has continued to have life threatening cardiac disease and chylothorax despite medical management. The treatment was reported to be nurse assessment and hospital inpatient, the patient required some nursing intervention with supportive therapy of oxygen and increased observation. The symptoms lasted two days. The event assessment was reported to be possible. The patient died on an unspecified date in Oct2014. It was not reported if an autopsy was performed.


VAERS ID: 558859 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-11-17
Entered: 2014-11-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Streptococcus test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-05
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: Unknown
Allergies:
Diagnostic Lab Data: 2014, CSF test, positive agglutination pneumococcal
CDC Split Type: 2014312112

Write-up: This is a spontaneous report from a contactable physician via a sales representative. A 2-years-old female patient received PREVENAR 13, via an unspecified route of administration on an unspecified date at single dose. It was reported that the patient had been completely vaccinated. The patient medical history and concomitant medications were not reported. In the exploration performed on an unspecified date in 2014, a positive agglutination pneumococcal in CSF was found. They were awaiting for the results of the serology to confirm the serotype. On 05Nov2014 the patient died. It was unknown if any autopsy was performed.


VAERS ID: 559031 (history)  
Form: Version 1.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-08-08
Submitted: 2014-11-19
   Days after onset:103
Entered: 2014-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Cellulitis, Death, Escherichia test positive, Intensive care, Resuscitation, Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-08-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood culture, E. Coli
CDC Split Type: WAES1411NLD007357

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR# E2014-10850) as part of business agreement on 14-NOV-2014. Fatal study case received on 10-Nov-2014 under the protocol reference NL28557.000.09 and identification number AE014.14.28557. Seriousness criterion: septic shock, death. Medically confirmed. A male patient 54 year old had received the ZOSTAVAX (batch number not reported) on an unspecified date. On 08/AUG/2014 the subject was transferred to Intensive Care Unit with septic shock, rapidly progressive phlegmon on the right side and E.Coli in haemoculture. Despite respiratory and circulatory support, need for resuscitation; not successful. Deceased on 09/08/2014 at 02.50 a.m. Additional information: result of autopsy will follow.


VAERS ID: 559262 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-06
Onset:2014-11-07
   Days after vaccination:1
Submitted: 2014-11-20
   Days after onset:13
Entered: 2014-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K003489 / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apathy, Aspiration, Asthenia, Blood lactic acid increased, Body temperature decreased, Bradycardia, Cardiac failure acute, Cold sweat, Death neonatal, Dyspnoea, Electrocardiogram abnormal, Hyperlactacidaemia, Hypoxia, Ischaemia, Oxygen saturation decreased, Resuscitation, Shunt occlusion, Tachycardia, Tachypnoea, Thrombocytopenia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-11-07
   Days after onset: 0
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: SYNAGIS
Current Illness: Immunisation
Preexisting Conditions: Chylothorax; Supraventricular tachycardia; Restlessness; Hypoplastic left heart syndrome; Cardiac failure; Atrial septal defect; 10/06/2014, SYNAGIS, dose 1, No adverse event
Allergies:
Diagnostic Lab Data: 11/06/2014, Body temperature, 36 degrees C; 11/07/2014, Electrocardiogram, No heart pumping
CDC Split Type: WAES1411DEU008711

Write-up: Information was received from Sanofi Pasteur MSD (DE-1577272925-E2014-10934) on 18-NOV-2014. Case of fatal outcome was received from the Health Authorities on 13-NOV-2014 (reference no. PEI2014072506). Case is medically confirmed. An 8-week-old male patient with a medical history of hypoplastic left heart syndrome, restrictive atrial septal defect, cardiac insufficiency, supraventricular tachycardia, periods of marked restlessness in terms of potential angina abdominalis caused by the shunt, and chylothorax, who had undergone Norwood I procedure on 12-SEP-2014 and secondary surgical closure of the thorax on 13-SEP-2014, received a first dose of ROTATEQ (lot-no. K003489, expiration date not reported) orally on 06-NOV-2014. Additionally he received a second dose of SYNAGIS (lot-no. 43524TF). In the evening of that day, he developed tachycardia up to 175/min, apathy (did not stir for feeding), tachypnoea and cold sweat and was "more asthenic" (not coded by HA). Body temperature was 36 degrees C. He was hospitalised on the same day. Lab analysis already showed conspicuous lactataemia (5mmol/l) and thrombopenia (60,000/mcl). The following morning, on 07-NOV-2014 he developed acute decrease of oxygen saturation, bradycardia and gasping. Resuscitation was without success. ECG revealed no heart pumping actions anymore. He died on 07-NOV-2014 at 7:40am (exitus letalis according to hospital report). Differential diagnosis included suspicion of acute shunt occlusion, ischaemic and acute cardiac insufficiency, aspiration with hypoxia. "Possible vaccination reaction" was mentioned. Autopsy was planned. Patient received a first dose of SYNAGIS on 06-OCT-2014 which was tolerated well. Additional information received from the Health Authority on 18-NOV-2014: The cause of death is unknown at the time of reporting.


VAERS ID: 559480 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-11-21
Entered: 2014-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1411CAN008895

Write-up: This spontaneous report as received from a physician via a sales representative, refers to a patient of unknown gender and age. On an unknown date the patient was vaccinated with GARDASIL. No other co-suspects were reported. No concomitant medications were reported. The reporting physician stated that one of his patients has a friend who''s child died as a result of GARDASIL vaccination. A response to a follow-up request was received from the clinic on 19Nov2014. The reporter (unknown) stated that the patient that passed away was not a patient of the reporting physician. The patient was a family friend of the physician''s patient. Physician does not have any information on the deceased. No further information was provided. It is unknown if death was related to GARDASIL. Additional information is not expected.


VAERS ID: 559636 (history)  
Form: Version 1.0  
Age: 0.11  
Sex: Male  
Location: Foreign  
Vaccinated:2014-07-03
Onset:0000-00-00
Submitted: 2014-11-24
Entered: 2014-11-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER - / 1 UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014318620

Write-up: This is a spontaneous report from a contactable nurse via the Health Window Patient Support Program. A 5-month-old male patient started to receive PREVENAR 13, intramuscular on 03Jul2014 first dose and on Oct2014 second dose at 1 DF, via an unspecified route of administration, PENTAXIM intramuscular from 03Jul2014 to 03Jul2014 at 0.5 ml, single (STAT) for whooping cough, hepatitis B vaccine, intramuscular from 03Jul2014 to 03Jul2014 at 0.5 ml, single (STAT) for hepatitis B and ROTARIX, oral on 03Jul2014 at drops, single dose. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient sustained injuries during a motor vehicle accident on an unspecified date. The action taken in response to the event for PREVENAR 13, PENTAXIM, hepatitis B vaccine and ROTARIX was not applicable. The patient died on Oct2014. The nurse also reported that she spoke to the mother. Baby passed away due to injuries sustained in a motor vehicle accident in Oct2014. Baby received first 2 doses of PREVENAR 13 before the accident. The patient was a healthy baby without chronic diseases. It was not reported if an autopsy was performed.


VAERS ID: 559874 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-10-09
Onset:2014-10-21
   Days after vaccination:12
Submitted: 2014-11-26
   Days after onset:36
Entered: 2014-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-21
   Days after onset: 0
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: WAES1411JPN010885

Write-up: Information has been received from a patient''s family concerning a 79 year old female patient. On 09-OCT-2014 the patient was vaccinated at hospital A with PNEUMOVAX NP (lot #, expiration date and dose not reported), subcutaneous. There was no concomitant medication reported. On 21-OCT-2014, the patient died of pneumonia. The autopsy information was not provided. Comment of the reporter: Not reported. The reporter considered that the pneumonia was serious due to death. The reporter did not assess the relationship of pneumonia to PNEUMOVAX NP. Additional information is not expected because the reporter did not wish to be contacted.


VAERS ID: 560062 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-19
Onset:2014-11-19
   Days after vaccination:0
Submitted: 2014-11-26
   Days after onset:7
Entered: 2014-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-19
   Days after onset: 0
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: SV2014GSK025322

Write-up: This case was reported by a physician via sales rep and described the occurrence of aspiration in a 4-month-old male patient who received ROTARIX. Co-suspect products included OPV, DTP-HepB/Hib and PCV13. On 19th November 2014, the patient received ROTARIX, OPV, DTP-HepB/Hib and PCV13. On 19th November 2014, 0 min after receiving ROTARIX, OPV, DTP-HepB/Hib, the patient experienced aspiration (serious criteria death and GSK medically significant). On 19th November 2014, the outcome of the aspiration was fatal. The patient died on 19th November 2014. The reported cause of death was aspiration. An autopsy was performed. The autopsy determined cause of death was aspiration. The reporter considered the aspiration to be unrelated to ROTARIX, OPV, DTP-HepB/Hib. Additional information: This case was published on an online blog newspaper. Therefore the reporting physician gave details of the case to the sales representative.


VAERS ID: 560101 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2014-09-18
Onset:2014-09-27
   Days after vaccination:9
Submitted: 2014-11-25
   Days after onset:59
Entered: 2014-11-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR K1118 / 2 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 13K02A / 2 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Bradycardia, Cardiac massage, Cyanosis, Death, Depressed level of consciousness, Endotracheal intubation, Gastrointestinal tube insertion, Heart rate decreased, Nausea, Pallor, Pericardial haemorrhage, Resuscitation, Tachycardia paroxysmal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-27
   Days after onset: 0
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: Extremely low birth weight baby, birth weight at 500 g; Lung disorder
Allergies:
Diagnostic Lab Data: 18-SEP-2014, Body temperature, 36.6 Centigrade; 27-SEP-2014, Heart rate, around 100-130; 27-SEP-2014, Heart rate, bradycardia; 27-SEP-2014, Heart rate, paroxysmal tachycardia
CDC Split Type: 2014318554

Write-up: This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number V14000585. A 6-month-old female patient of an unspecified ethnicity received the second dose (0.5 ml single) of PREVENAR 13 (lot number: 13K02A, expiration date: 30Sep-2016) and the second dose (1 dosage form single) of ACTHIB (lot number: K1118), both subcutaneously at 10:00 a.m. on 18Sep2014. The patient''s body temperature before vaccination was 36.6 degrees C on the same date. Medical history included extremely low birth weight baby with birth weight at 500 g, chronic lung disease and pulmonary hypertension. The patient received oxygen supplementation. The patient''s concomitant medications were not reported. Clinical course was reported as follows: on 27Sep2014, queasy, ill complexion and paroxysmal tachycardia occurred after gastric tube insertion. Paroxysmal tachycardia spontaneously disappeared after about 15 minutes. However, paroxysmal tachycardia recurred, which suddenly led to cyanosis. Pulse rate decreased to around 100-130 bpm. Decreased level of consciousness was observed. The patient was intubated, but bradycardia occurred. Resuscitation including cardiac massage and administration of BOSMIN was performed, but the patient responded poorly. The patient died of an unknown cause on the afternoon of the same date. On the later date, autopsy was performed, which revealed hemorrhage around atrioventricular node. The reporting physician (attending physician) classified the case as serious due to death, while causality assessment to PREVENAR 13 and ACTHIB was not provided.


VAERS ID: 560118 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-05-21
Onset:2014-05-21
   Days after vaccination:0
Submitted: 2014-11-25
   Days after onset:188
Entered: 2014-11-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI086AE / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dysphonia, Dyspnoea, Hypotonia, Pyrexia, Somnolence, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-05-27
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Antiinflammatory/Antirheumatic products; Antacids; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Body temperature
CDC Split Type: 2014SA159354

Write-up: This case report is part of a batch of reports associated with several products that was received on 13 November 2014 by our partner who received the report from the ministry of health. Partner forwarded the batch of cases to Sanofi Pasteur on 14 November 2014. A female patient, age reported as 87 years 03 months, with medical history of hypertension, had received single dose of FLUZONE, lot number UI086AE, by intramuscular route, in the right deltoid on 21 May 2014. The patient''s concomitant medications included anti-inflammatory and anti gas. On an unspecified date, the patient experienced dyspnea and hoarseness 5hrs after vaccination, hypotonia 6hrs after vaccination and fever. The reported diagnosis was death. It was reported that death was temporally associated with the use of influenza vaccine. Patient was 87 years old bedridden, with medical history of hypertension, having been suspended medication in a private consultation, using anti-inflammatory and anti gas (not specified products) on purchase through pharmacy. According to the family, the patient presented hoarseness, dyspnea, drowsiness and fever, not being forwarded to medical consultation. On 27 May 2014, she died. It was not tracked the death certificate. We solicited better feedback research from 05 June 2014, not received until the moment. The outcome was reported as death. The patient did not undergo a medical consultation. The case was reported as serious due to death by the regulatory authority.


VAERS ID: 560235 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:2014-06-29
Onset:2014-07-06
   Days after vaccination:7
Submitted: 2014-12-02
   Days after onset:149
Entered: 2014-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. J004868 / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Decreased appetite, Hyporesponsive to stimuli, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-07-06
   Days after onset: 0
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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Prevaccination examination (29-JUN-2014): normal; Body temperature (06-JUL-2014): increased
CDC Split Type: WAES1412MYS000277

Write-up: This spontaneous report as received from a regulatory authority (agency # was not provided) on 01-DEC-2014 refers to a 3 month old patient of unknown gender. On 29-MAY-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # J004868, expiration date: 31-DEC-2014) (strength and dose were unknown). On 29-MAY-2014 the patient was vaccinated with the first dose of INFANRIX HEXA (manufacturer: GlaxoSmithKline) and the first dose of PREVENAR 13 (manufacturer: Pfizer). After vaccinations, the child started having reduced feeding and gradually decreasing. On 29-JUN-2014, the pre-vaccination examination by physician was normal. On 29-JUN-2014, the patient was vaccinated with the second dose of ROTATEQ (lot # J004868, expiration date: 31-DEC-2014) (strength and dose were unknown) oral. On 29-JUN-2014 the patient was vaccinated with the second dose of INFANRIX HEXA (manufacturer: GlaxoSmithKline) and the second dose of PREVENAR 13 (manufacturer: Pfizer). The poor feeding further deteriorated after second vaccination. There was no fever, Upper Respiratory Tract Infection (URTI) or Arterial Gas Embolism (AGE) symptoms. On 06-JUL-2014 at 01:00 AM the fever was noted, the temperature was 38 degree Celsius. On 06-JUL-2014 at 04:00 AM the patient was noted less responsive. On 06-JUL-2014 at 05:17 AM, the patient passed away. The cause of death was not reported. The outcome of other events were not provided. The agency requested a lot check on lot J004868. Additional information has been requested.


VAERS ID: 560274 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-13
Onset:2014-11-15
   Days after vaccination:2
Submitted: 2014-11-27
   Days after onset:12
Entered: 2014-12-02
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J61509 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ramipril; LASIX; CARDICOR; COUMADIN; ANDROCUR
Current Illness:
Preexisting Conditions: Atrial fibrillation; Congestive heart failure; Atrioventricular block complete; Pacemaker insertion (cardiac); Cardiac pacemaker insertion due to total AV block; Hypertensive cardiomyopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014325717

Write-up: This is a spontaneous report received from a Regulatory Authority. Regulatory Authority report number 281268. A physician (contactable through Regulatory Authority only) reported that a 90-year-old male patient received the first dose (0.5 ml single) of PREVENAR 13 (lot number J61509; expiration date 31Jan2017), intramuscular on 12Nov2014. Relevant medical history included concomitant predisposing conditions as atrial fibrillation, congestive heart failure, cardiac pacemaker insertion due to total atrioventricular block, hypertensive cardiomyopathy, past hospitalization from an unspecified date with discharge on 15Oct2014 from the Cardiology Unit with indication to vaccination. Concomitant medications included ramipril, LASIX, CARDICOR, COUMADIN, ANDROCUR. On 15Nov2014, the patient experienced fever, other general reaction and he died the same day. The cause of death was reported as fever, other general reaction. It was unspecified if an autopsy was performed.


VAERS ID: 560284 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-09-16
Onset:2014-09-16
   Days after vaccination:0
Submitted: 2014-11-26
   Days after onset:71
Entered: 2014-12-02
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cerebral haemorrhage, Condition aggravated, Death, Electrocardiogram normal, Nasopharyngitis, Palpitations, Pyrexia, Tuberculosis, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-18
   Days after onset: 2
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; Atrial fibrillation; Palpitation; Arrhythmia; Common cold
Allergies:
Diagnostic Lab Data: 16-SEP-2014, Body temperature, no fever; 16-SEP-2014, Body temperature, fever; 17-SEP-2014, Body temperature, high fever; 16-SEP-2014, Electrocardiogram, normal, no abnormality
CDC Split Type: 2014320200

Write-up: This is a spontaneous report from a contactable physician via an Adult Vaccine Marketing Manager. A physician reported that a 64-year-old male patient was vaccinated with PREVENAR 13 on 16Sep2014. Medical history as of 16Sep2014 included hypertension, atrial fibrillation and palpitation; and an EKG was performed on 16Sep2014, which showed normal. Concomitant medication were not provided. At the time of visit on 16Sep2014, the patient had "symptom in throat and runny nose as common cold", and had no fever. As the symptoms of common cold was not severe, the physician recommended administration of PREVENAR 13. On the night of 16Sep2014, he experienced "fever a lot". Two days after that (on 18Sep2014) he had vomiting and passed away. At the time of his death, there was no one around him and he was alone. The physician was aware of his death since the caregiver of the patient visited the physician to demand compensation for damage at the end of October. The physician did not diagnose or carry out his death at first-hand at the time of his death. The physician wondered if report of incident regarding vaccination of PREVENAR 13 should be done by the physician in this case. And he wanted to know about compensation for damage. The patient died on 18Sep2014; the immediate cause of death was brain hemorrhage. Follow-up (20Nov2014): This is a follow-up report from the contactable physician received via Yuhan Corporation, manufacturer control number 2014-1122, license party for PREVENAR 13. The 64-year-old male who had history of arrhythmia and atrial fibrillation received PREVENAR 13 on 16Sep2014. The patient visited the reporter''s clinic due to feeling of common cold and took an examine for common cold and palpitation. After EKG, the physician diagnosed no abnormality and prescribed drugs for common cold. The patient wanted to receive vaccination for pneumonia, so the physician gave it. At the time of vaccination he had no fever. On the day of vaccination, fever occurred. On the following day (17Sep2014) he had a high fever. On 18Sep2014, he died after vomiting. Date of death was 18Sep2014. Cause of death was brain hemorrhage and tuberculosis. Autopsy was not done.


VAERS ID: 560289 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-27
Onset:2014-11-28
   Days after vaccination:1
Submitted: 2014-12-02
   Days after onset:4
Entered: 2014-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 148801A / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Enalapril; LOBIDIUR; ZANEDIP
Current Illness: Aortic stenosis; Hypertensive heart disease; Nasal turbinate hypertrophy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT157200

Write-up: Case number PHHY2014IT157200 is an initial combined spontaneous report received from a physician via Novartis employee on 29 Nov 2014 with a follow up information received from health care professional via health authority (HA reference number: 282036) on 01 Dec 2014 and a follow up information received from quality assurance department (QA reference number: 340231) on 02 Dec 2014. This report refers to a 68 years old male patient. His current conditions included aortic stenosis, hypertensive heart disease and nasal turbinate hypertrophy. His concomitant medications were enalapril 20 mg, LOBIDIUR 5mg/12.5 mg film coated tablet and ZANEDIP 10 mg coated tablet. He was vaccinated with first booster dose of AGRIPPAL S1 (batch number: 148801A) at a dose of 1 posologic unit intramuscularly on 27 Nov 2014. On 28 Nov 2014, he experienced arrhythmia. It was reported that on the same day he died due to cardio-circulatory arrest. The emergency service arrived and remarked the death. It was reported that autopsy was required (not reported whether it was performed or not). The reporter assessed the event as serious. The general practitioner stated that there was no relationship between death and administration of AGRIPPAL S1. The health authority reported that the event was suspected to be related with vaccination with AGRIPPAL S1.


VAERS ID: 560293 (history)  
Form: Version 1.0  
Age: 1.01  
Sex: Female  
Location: Foreign  
Vaccinated:2014-09-05
Onset:2014-09-06
   Days after vaccination:1
Submitted: 2014-11-27
   Days after onset:82
Entered: 2014-12-02
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Death, Electroencephalogram abnormal, Nuclear magnetic resonance imaging brain abnormal, Respiratory tract infection, Resuscitation
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Prematurity, birth at 28 weeks of amenorrhea and 5 days in the context of chorioamnionitis; Hyaline membrane disease, severe; Pulmonary hypoplasia, left; Bronchopulmonary dysplasia; Bronchiolitis, requiring increased oxygen therapy; APR-2014 to Unknown, Hospitalization, due to bronchiolitis; Respiratory tract infection; Pulmonary arterial pressure abnormal, via the coronary sinus to the right atrium; 10-DEC-2013 to Unknown, Cardiac operation; Pulmonary arterial hypertension; Cerebellar hematoma, right cerebellar hematoma (8 mm) with mildly enlarged lateral ventricles; OCT-2013, PREVENAR-13, 1st dose; PREVENAR-13, 2nd dose; MAR-2014, PREVENAR-13, 3rd dose; OCT-2013, INFANRIX HEXA, 1st dose; MAR-2014, INFANRIX HEXA, 2nd dose; 25-FEB-2014, SYNAGIS; Unknown to 05-SEP-2014, Hospitalization
Allergies:
Diagnostic Lab Data: Electroencephalogram, asymmetric strip with less large left traces; 15-JAN-2014, Nuclear magnetic resonance imaging brain, right cerebellar hematoma (8 mm)
CDC Split Type: 2014321707

Write-up: This is a spontaneous report received from the Agency. Regulatory Authority report number FR-AFSSAPS-NT20141293. A 12 months old female patient received on 05Sep2014 in the morning the fourth dose of PREVENAR 13 at 0.5 ml single and the third dose of INFANRIX HEXA at 1 DF single. Relevant medical history included premature birth at 28 weeks and 5 days post-last menstrual period in the context of chorioamnionitis, severe hyaline membrane disease with left pulmonary hypoplasia followed by bronchopulmonary dysplasia, hospitalization for bronchiolitis in Apr2014 requiring increased oxygen therapy, respiratory tract infection, total abnormal venous flow via the coronary sinus to the right atrium leading to cardiac surgery on 10Dec2013. The post-operative course was marked by pulmonary arterial hypertension. Regarding neurologic condition: electroencephalogram showing asymmetric strip with less large left traces, brain magnetic resonance imaging on 15Jan2014 showing right cerebellar hematoma (8 mm) with mildly enlarged lateral ventricles. Concomitant medications included oxygen therapy as long-term treatment, for bronchopulmonary dysplasia. Past drug history included vaccinations with PREVENAR 13 in Oct2013 (first dose), on unknown date (second dose) and in Mar2014 (third dose) and with INFANRIX HEXA in Oct2013 (first dose) and in Mar2014 (second dose). The patient was also received SYNAGIS according to vaccination schedule on 25Feb2014. On 05Sep2014, the patient was discharged after a respiratory tract infection and he was vaccinated in the morning. The patient was the subject of unexplained death on 06Sep2014. On 06Sep2014, the child was brought to hospital at 6:20 AM presenting with cardiorespiratory arrest. He was treated with cardiopulmonary resuscitation attempt with 7 doses of epinephrine and 1 dose of calcium gluconate (unspecified trade name). The patient died on 06Sep2014 at 7:05 AM, from unknown cause. Based on the Official Method of Causality Assessment and updated Method of Causality Assessment the causal relationships between the suspect vaccines and the adverse event death unexplained were assessed by the Agency as "doubtful". No follow-up attempts needed. No further information expected.


VAERS ID: 561032 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-02-01
Onset:2014-02-01
   Days after vaccination:0
Submitted: 2014-11-27
   Days after onset:299
Entered: 2014-12-03
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTIPV: DT + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Death, Headache, Internal haemorrhage, Pyrexia, Staphylococcal infection
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (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: 2014-02-28
   Days after onset: 27
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: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown; No information reported
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA163295

Write-up: Case was imported from SPMSD under the reference number E2014-11124. Case received via a media press article on 17-Nov-2014. A 17-year-old male patient had received a dose of DT-IPV (Manufacturer unknown) in Feb-2014. The vaccine had been administered by the family physician. On the evening post-vaccination, the patient complained from headache and fever. He visited the physician several times in the following days. The physician prescribed antipyretic treatment and blood work-up. According to him, the patient was suffering from adverse events secondary to his vaccination but there was nothing to worry about. After ten days the patient''s state worsened and he was taken to the Emergency Unit Care. A staphylococcal infection was evidenced. The patient was hospitalized during one week. He died on 28-Feb-2014 from an internal hemorrhage subsequently to a convulsive seizure. The parents of the patient filed a complaint against the physician and the hospital. According to them, their son died from a staphylococcus aureus, which was poorly treated.


VAERS ID: 561538 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2014-01-01
Onset:2014-07-26
   Days after vaccination:206
Submitted: 2014-12-04
   Days after onset:131
Entered: 2014-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Death, Diarrhoea, Gastroenteritis, Vaccination failure, Vomiting
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-07-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ID2014GSK028596

Write-up: This case was reported by a physician and described the occurrence of acute gastroenteritis in a 1-year-old female patient who received ROTARIX. Co-suspect products included ROTARIX. On an unknown date, the patient received the 1st dose of ROTARIX (oral). In January 2014, the patient received the 2nd dose of ROTARIX (oral). On 26th July 2014, 183 days after receiving ROTARIX and less than a year after receiving ROTARIX, the patient experienced acute gastroenteritis (serious criteria death and hospitalization), vomiting, diarrhoea, abdominal distension and possible vaccination failure (serious criteria GSK medically significant). 28th July 2014, the outcome of acute gastroenteritis was fatal. On an unknown date, the outcome of the vomiting, diarrhoea, abdominal distension and possible vaccination failure were unknown. The patient died on 28th July 2014. The reported cause of death was acute gastroenteritis. The reporter considered the acute gastroenteritis, vomiting, diarrhoea, abdominal distension and possible vaccination failure to be related to ROTARIX. Additional details were provided as follows: On 26th July 2014, the patient was hospitalized. The reporting physician did not know the details of the treatment and that of the patient''s condition during hospitalization. After 2 days of hospitalization, the patient died due to acute gastroenteritis. Although the reporting physician mentioned gastroenteritis was probably due to lack of efficacy of the vaccine, no lab tests were available to confirm the etiology of the event.


VAERS ID: 561597 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2014-05-29
Onset:2014-05-29
   Days after vaccination:0
Submitted: 2014-12-04
   Days after onset:189
Entered: 2014-12-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J13338 / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Hyporesponsive to stimuli, Poor feeding infant, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-07-06
   Days after onset: 38
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Body temperature, no fever; 06-JUL-2014, Body temperature, 38 Centigrade; Investigation, normal
CDC Split Type: 2014328818

Write-up: A 3-month-old female patient received two doses of PREVENAR 13, first dose (lot/batch J13338) on 29May2014 and second dose (lot/batch J13338) on 29Jun2014, both at single dose. Patient also received first and second dose of INFANRIX HEXA and first and second dose of ROTATEQ, each one respectively on 29May2014 and on 29Jun2014, together with PREVENAR 13. Relevant medical history and concomitant medication were not reported. On 29May2014, after the vaccinations, patient started having reduced feeding, gradually decreasing. On 29Jun2014, prevaccination examination was done by physician which resulted normal and patient received the second dose of the vaccines. Patient''s poor feeding deteriorated following the second set of vaccinations. It was also reported that there was no fever, URTI or AGE symptoms. On 06Jul2014 at 1am, patient was noted to have fever at 38 degree C. On 06Jul2014 at 4am the patient was less responsive. The patient passed away on 06Jul2014 at 5.17am. It is unknown if autopsy was done, hence cause of death was unknown. The events were reported as fatal.


VAERS ID: 562176 (history)  
Form: Version 1.0  
Age: 0.23  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-24
Onset:2014-11-24
   Days after vaccination:0
Submitted: 2014-12-05
   Days after onset:11
Entered: 2014-12-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia, Body temperature decreased, Haemorrhage, Increased bronchial secretion, Musculoskeletal stiffness, Pyrexia, Respiratory tract infection, Resuscitation, Rhinorrhoea, Skeletal survey normal, Sudden infant death syndrome
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Arthritis (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-25
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DOLIPRANE
Current Illness:
Preexisting Conditions: 17-NOV-2014, Rhinopharyngitis, Treated with unspecified symptomatic treatment which led to clinical improvement; OCT-2014, BCG antituberculosis vaccination
Allergies:
Diagnostic Lab Data: 24-NOV-2014, Body temperature, slightly febrile; 25-NOV-2014, Body temperature, 33.6; 25-NOV-2014, Body temperature, no fever; 25-NOV-2014, Laboratory test, pending results; Physical examination, normal growth, 24-NOV-2014, Physical examination, normal; 25-NOV-2014, Skeletal survey, normal
CDC Split Type: 2014330228

Write-up: This is an initial spontaneous report received from the Agency, regulatory authority report number PC20140557. A 02-month and 23 day-old male patient received one dose of the following suspect vaccines, according to the vaccination calendar, on 24Nov2014: PREVENAR 13 0.5ml single by intramuscular route and INFANRIX HEXA by intramuscular route. Suspect products also included DOLIPRANE 2.4% orally on 24Nov2014 unspecified posology and indication. The patient was born following a normal full-term pregnancy and delivery and he had exclusively breastfeeding. At the age of one month, he was seen in the maternal and child health center for consultation, revealing normal growth. At this time he received BCG. Medical history also included simple rhinopharyngitis on 17Nov2014 for which he was seen in an emergency service. The patient received symptomatic treatment leading to clinical improvement. On 24Nov2014 at 11:30 a.m, a second month consultation in the maternal and child health center showed normal examination and vaccination as described above was performed at two different injection sites. On 24Nov2014 in the evening, he presented mild fever (body temperature not measured), and paracetamol was instituted. The night between 24 and 25Nov2014 was uneventful with 2 breast feedings, as usual. No additional medical history was reported. No concomitant treatment was reported. The patient experienced sudden infant death syndrome on 25Nov2014. On 25Nov2014, the patient was fed around 8:30 a.m and he drank less than usual. He was not warm (no fever), his behavior was considered as normal. At 9:00 a.m., the mother entrusted the infant to her friend. Her friend went out with the infant from 10 a.m. to 11 a.m., placed in a baby carrier backpack. When she returned home, the mother''s friend thought that the baby was sleeping, she took him out from the baby carrier and laid him down in a baby bed on his back. She couldn''t specify whether he was alive at that moment, information which was considered as more than doubtful according to the emergency services. Shortly after, the mother arrived and found her son dead on his back, already stiff with rose and foamy secretion from his nose. The emergency services were called. Resuscitation was unsuccessful. Intubation was impossible, the infant was stiff; the body temperature taken by the emergency service was 33.6 degree C at 00:45 pm. The infant was received in an unexpected infant death circuit. Clinical examination found weight of 6 kg, the patient was eutrophic without sign of violence. Tracheal secretions were abundant, foamy and mildly bloody. Laboratory investigations were performed, results were pending. Skeleton X-ray was normal. Medical autopsy was refused. The referent physician from the unexpected death infant center concluded to probable asphyxia accident while carrying the infant in the backpack, with possible aggravating role of a respiratory infection and/or of fever, or of a post vaccination reaction, which could have limited the baby''s reactivity and awakening in hypoxia-hypercapnia situation secondary to a stifled face in the baby carrier. Based on the Official Method of Causality Assessment, the causal relationships between the suspect products and the sudden infant death syndrome were assessed by the Agency as "doubtful". No FU attempts needed. No further information expected.


VAERS ID: 562269 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-03
Onset:2014-11-05
   Days after vaccination:2
Submitted: 2014-12-08
   Days after onset:33
Entered: 2014-12-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 149201 / UNK AR / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cardio-respiratory arrest, Death, Malaise, Sepsis, Septic shock
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), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-11
   Days after onset: 6
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: Renal failure chronic, since 10 years; Ischaemic cardiomyopathy, since 09 years; Chronic obstructive pulmonary disease, since 10 years; Coronary artery disease; 2013, Ischaemic stroke
Preexisting Conditions: Aortic aneurysm rupture
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT158295

Write-up: Case number PHHY2014IT158295, is an initial spontaneous report from a health care professional via Health Authority (HA, reference number: 282680) received on 03 Dec 2014. This report refers to an 85-year-old male patient. The patient current conditions included chronic renal failure (since 10 years), ischemic cardiomyopathy (since 9 years), COPD (since 10 years) and coronary artery disease. Historical condition included previous rupture of aortic aneurysm and ischemic stroke (in 2013). He was vaccinated with AGRIPPAL (batch number: 149201) into the deltoid on 03 Nov 2014. On 05 Nov 2014, the patient experienced malaise (patient relative referred as malaise). Based on the necroscopic record and sequence of condition that conducted directly to death were reported as: on 06 Nov 2014 (5 days before the date of death), the patient had an infection of unknown origin and the patient was taken to hospital. On 07 Nov 2014, the patient was hospitalized. On 09 Nov 2014 (2 days before the date of death), the patient had septicemia. On 10 Nov 2014 (1 day before the date of death), the patient had septic shock. On 11 Nov 2014, the patient had cardio-respiratory arrest and the patient died. The reporter assessed the event to be serious (death) and causality to be suspected to the administration of AGRIPPAL.


VAERS ID: 562407 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-19
Submitted: 2014-12-05
   Days after onset:16
Entered: 2014-12-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 149502A / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Bronchopneumonia, Catarrh, Cough, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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: 2014-11-24
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LASIX
Current Illness: Cardiac disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT158290

Write-up: Case number PHHY2014IT158290 is an initial spontaneous report received from a healthcare professional via Health Authority (HA reference number: 282543) on 03 Dec 2014. This report refers to a 95 year old female patient. Her current conditions included a heart disease and concomitant medications included LASIX (25 mg tablets) at a dose of 50 mg orally. On an unspecified date, she was vaccinated with AGRIPPAL (batch number: 149502A). On 19 Nov 2014, the patient had mild fever. On 20 Nov 2014, she had fever, catarrh and cough. On 24 Nov 2014, she had suspected outbreak of bronchopneumonic on the left characterised by fever, cough, catarrh, dyspnea, gasps and reduced vesicular murmur on the left. It was reported that the fever was of unknown origin. The patient died on 24 Nov 2014. The health authority assessed the causality of the events as suspected to be related to the administration of AGRIPPAL.


VAERS ID: 562266 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-10-27
Onset:2014-10-27
   Days after vaccination:0
Submitted: 2014-12-10
   Days after onset:44
Entered: 2014-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 27649411A / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Circulatory collapse, Death, General physical health deterioration
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), 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), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Allopurinol; Lisinopril; Atorvastatin; Clopidogrel
Current Illness:
Preexisting Conditions: COPD; Aortic valve insufficiency; Coronary sclerosis; Aneurysm of renal artery
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014046911

Write-up: This medically confirmed health authority report (initial receipt 26-Nov-2014) concerns a 73-year-old male patient. The patient''s medical history included chronic obstructive pulmonary disease, aortic valve insufficiency, coronary sclerosis and aneurysm of renal artery. His concomitant medications included allopurinol, lisinopril, atorvastatin and clopidogrel. On 27-Oct-2014, the patient received intramuscular AFLURIA (batch number: 27649411A) at 1 DF. On 27-Oct-2014, six hours after vaccination, the patient developed cardiac failure, circulatory failure and reduced general condition (lasting for unknown). The patient died. An autopsy was not performed. It was reported that the patient had a fatal outcome. Reporter''s comments: Unexpected adverse drug reaction, 6 to 8 hours after vaccination and from complete well-being, sudden deterioration of physical health and cardiac failure/circulatory arrest. The patient received reanimation by emergency service which was aborted without successful outcome. The health authority assessed the case as serious (patient died). Cause(s) of death: Unknown cause of death. Death Date: 27-Oct-2014.


VAERS ID: 562420 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-10
Onset:2014-11-10
   Days after vaccination:0
Submitted: 2014-12-10
   Days after onset:30
Entered: 2014-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR L8287 / 1 UN / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. K009023 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cerebral thrombosis, Death, Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-20
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CARDIOASPIRIN; CORLENTOR; TAPAZOLE; PEPTAZOL; CLENIL; BREVA
Current Illness: Prophylaxis against gastrointestinal ulcer; Immunisation; Bronchial disorder; Goitre; Hypertensive heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1412ITA003923

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control number IT-1577272925-E2014-12205) on 08-DEC-2014. Case received from Health Authority (case n. 283387) on 05-DEC-2014. Case initially reported by a physician. Case medically confirmed. A 90 year old patient was vaccinated on 10-NOV-14 with the first dose of INTANZA (batch n. L8287-2, Exp. date 30/06/2015) I.M. and with one dose of PNEUMOVAX (batch number K009023, Exp. date 30/04/2015). On the same day he presented with ischemic stroke and cerebral thrombosis. The patient was hospitalized. He was treated with parenteral nutrition, hydration and diuretic. On 20-NOV-14 the patient died. The outcome is fatal. The patient''s medical history included hypertensive heart disease, goiter and bronchopathy. Concomitant medications included CARDIOASPIRIN, CORLENTOR, TAPAZOLE, PEPTAZOL, CLENIL and BREVA. The case is closed.


VAERS ID: 563238 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Male  
Location: Foreign  
Vaccinated:2014-09-19
Onset:0000-00-00
Submitted: 2014-12-09
Entered: 2014-12-11
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER A013C / 1 UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR K1026 / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 13K01A / 1 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: C-reactive protein increased, Circulatory collapse, Convulsion, Death, Liver function test abnormal, Pyrexia, Renal function test abnormal, Tachycardia, White blood cell count increased
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Trisomy 18; Extremely low birth weight baby; Tracheomalacia; Bronchomalacia; Ventricular septal defect
Allergies:
Diagnostic Lab Data: 19-SEP-2014, Body temperature, 36.5 Centigrade; 20-SEP-2014, Body temperature, pyrexia; SEP-2014, C-reactive protein, 2.4 mg/dl; 20-SEP-2014, Heart rate, 180-220; SEP-2014, Liver function test, mild elevation; SEP-2014, Renal function test, mild elevation; SEP-2014, White blood cell count, 16000/mm3
CDC Split Type: 2014332971

Write-up: This is a spontaneous report from a contactable physician received from regulatory authority. Regulatory authority report number of V14100709. A 13-month-old male patient received the 1st dose of PREVENAR 13 (Lot 13K01A, expiration date: 30Sep2016) at 0.5 ml single, the 1st dose of QUATTROVAC (Lot A013C) at 1 DF single, and the 1st dose of ACTHIB (Lot K1026) at 1 DF single, each of them was given subcutaneously on 19Sep2014 at 16:00. Medical history included trisomy 18, extremely low birth weight baby, tracheomalacia, bronchomalacia, and ventricular septal defect. Concomitant medications were not reported. Body temperature prior to the vaccinations on 19Sep2014 was 36.5 degrees Centigrade. Medical history in family members was reported as "not particular". The patient developed pyrexia, tachycardia and convulsion on 20Sep2014 and also developed circulatory failure on an unspecified date in Sep2014. Clinical course was reported as follows: Around 12 hours after the above mentioned vaccinations, pyrexia and tachycardia developed on 20Sep2014. The patient was being under observation with care such as cooling, but the symptoms appeared intermittently. Around at 20:00 on 20Sep2014, tachycardia persisted and convulsion-like movement appeared. Heart rate was 180-220 bpm (beat per minute) on 20Sep2014. Although unspecified anticonvulsant drug and antipyretic drugs were administered, no change was seen. Significant aggravation of peripheral circulatory was noted, which developed into circulatory failure (on unspecified date in Sep2014) and the patient died on 21Sep2014. No information was provided whether autopsy was performed or not. Other relevant lab data on an unspecified date in Sep2014 included mild elevation in liver and renal function, increase in WBC (white blood cell count): 16000/mm3 and CRP (C-reactive protein): 2.4 mg/dL. The reporting physician classified the events as serious due to fatal outcome and commented as follows: Although it was considered there could be other possible causal factor, it was judged that the events were related to the vaccinations because the patient who had been in stable condition developed very rapid aggravation of condition on the following day of the vaccinations.


VAERS ID: 563240 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2014-10-03
Onset:2014-10-06
   Days after vaccination:3
Submitted: 2014-12-09
   Days after onset:64
Entered: 2014-12-11
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR L4019 / UNK RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J45721 / UNK LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Loss of consciousness, Resuscitation, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-10-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: JUL-2014, Apgar score, 10-10-10; JUL-2014, Physical examination, Normal; SEP-2014, Physical examination, Normal; JUL-2014, Weight, 2930 g
CDC Split Type: 2014332154

Write-up: This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number SE-MPA-2014-6561. A 3-month-old female patient of an unspecified ethnicity received PREVENAR 13 (J45721) in the left thigh and PENTAVAC (Lot Number: L4019-1) in the right thigh, both intramuscular on 03Oct2014 at single doses. The patient''s medical history and concomitant medications were not reported. On 06Oct2014, the patient experienced sudden infant death syndrome (SIDS) resulting in death. The clinical course was as follows: in Jul2014, the patient was born in week 39 and 2 days, birth weight 2930 g, and Apgar scores of 10-10-10. The patient was checked after 24 hours and also at approximately 2 months of age (in Sep2014) without any noted problems. She was vaccinated on 03Oct2014. On 06Oct2014, at lunch time, she arrived at the emergency. Thirty minutes before this, she had been found unconscious at home. Resuscitation was without results and cardiopulmonary resuscitation was stopped. The physician was informed about the death on 20Nov2014 from the mother. The physician had been in telephone contact with the responsible pediatrician at the hospital but the autopsy was not yet completed. The regulatory authority assessed the causal relationship of the event, SIDS, with the suspect products, PREVENAR 13, and QUATTROVAC, as possible.


VAERS ID: 558289 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-12-11
Entered: 2014-12-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Intussusception
SMQs:, Gastrointestinal obstruction (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: The case fulfilled the Brighton Collaboration Criteria for level 1.
CDC Split Type: US2014GSK034489

Write-up: This case was reported in a literature article and described the occurrence of intussusception in a infant unk subject who received Rotavirus vaccine. On an unknown date, less than a week after receiving Rotavirus vaccine the subject developed intussusception. Serious criteria included death, hospitalization and GSK medically significant. Additional event(s) included unknown cause of death with serious criteria of death and GSK medically significant. The outcome of intussusception was fatal. The outcome(s) of the additional event(s) included unknown cause of death. The reported cause of death was unknown cause of death. The investigator considered the intussusception to be almost certainly related to Rotavirus vaccine. It was unknown if the investigator considered the unknown cause of death to be related to Rotavirus vaccine. Relevant Tests: The case fulfilled the Brighton Collaboration Criteria for level 1. Additional information received: This case was reported in a literature article and it described the occurrence of intussusception in an infant of unspecified gender, born after 1 August 2007 and between 6 and 35 weeks old, who had received ROTARIX (GlaxoSmithKline). No further information on the patient''s medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, the patient received the first dose of ROTARIX (oral; dosage unknown; batch numbers not provided). On an unspecified date between August 2008 and August 2010, 1 to 7 days after receiving the vaccine, the patient was hospitalised with a case of intussusception that according to the authors fulfilled the Brighton Collaboration Criteria for level 1. The patient later died. Cause of death was unspecified. It was unknown if a postmortem was performed. Treatment was unknown. The outcome of the event was fatal. The authors stated that they had identified an association between intussusception and the first dose of ROTARIX vaccination among infants in a specific country. The authors concluded that "In conclusion, in a specific country, RV1 was associated with an increased risk of intussusception in the first week after vaccination. In another country, a risk was not seen after dose 1, but a possible risk was noted in the first week after dose 2. These increased risks translated to an annual excess of 96 hospitalizations for intussusception and 5 deaths in the two countries combined, figures that were outweighed by the real-world benefits of RV1 vaccination, which had annually prevented more than 80,000 hospitalizations and 1300 deaths in these two countries. These emerging data on safety and benefits have been reviewed by the WHO as well as by regulatory agencies and immunization advisory committees in three countries. Although a risk of intussusception associated with rotavirus vaccination has not been documented in specific infants, the Advisory Committee on Immunization Practices reviewed modeling data under a scenario of risk similar to that seen in specific country. Considering that the real-world benefits of vaccination far outweigh the potential short-term risk of intussusception associated with the vaccine, these groups unanimously favoured continuing the recommendation that rotavirus vaccination be administered to infants to prevent severe and potentially fatal rotavirus disease."


VAERS ID: 565216 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-12-11
Entered: 2014-12-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Foetal exposure during pregnancy, Stillbirth, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2014031205

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of stillbirth in a patient exposed to BOOSTRIX in utero. Co-suspect product exposures included Influenza vaccine unspecified. On 10th October 2014, the mother received BOOSTRIX and Influenza vaccine unspecified. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient was diagnosed with stillbirth (serious criteria death and GSK medically significant). On an unknown date, the outcome of the stillbirth was fatal. The reported cause of death was stillbirth. An autopsy was not performed. It was unknown if the reporter considered the stillbirth to be related to BOOSTRIX and Influenza vaccine unspecified. Verbatim: Patient with low risk uncomplicated pregnancy received routine seasonal influenza and pertussis vaccine at community midwife clinic. Sudden onset heavy vaginal bleeding less than 12 hours after the vaccination resulting in a catastrophic placental abruption. Medically Significant Details: Catastrophic placental abruption with loss of 30 weeks (30/40) infant who was stillborn. The patient (mother) was taking 1. seasonal flu vaccine, 2. whooping cough vaccine for pregnancy.


VAERS ID: 567059 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-12-17
Entered: 2014-12-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 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: PREVENAR 13, first dose; NEISVAC-C
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014335089

Write-up: The initial case was missing the following minimum criteria: identifiable patient. Upon receipt of the follow-up information on 11Dec2014, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 5 month old child of unspecified gender and ethnicity received the second dose of PREVENAR 13, single dose. The patient had also been vaccinated with a first dose of PREVNAR 13 and NEISVAC-C (it was not known if the vaccines were administered concomitantly). On unknown date the patient died (unknown cause of death). No further information expected. No follow-up possible.


VAERS ID: 558971 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2014-12-11
Onset:2014-12-12
   Days after vaccination:1
Submitted: 2014-12-18
   Days after onset:6
Entered: 2014-12-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA172538

Write-up: Initial report received from healthcare professional on 12 Dec 2014. A 02-month-old female patient, whose medical history and concomitant medications were not reported, had recevied 0.5 ml intramuscular first dose of IMOVAX POLIO (lot number and site of vaccination not reported) on 11 Dec 2014 at 14:00 hours. It was reported that on 12 Dec 2014 at 02:00 hours, the parents found the patient dead. Autopsy details were not reported. Documents held by sender: None.


VAERS ID: 569102 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-06-06
Onset:2014-09-11
   Days after vaccination:97
Submitted: 2014-12-19
   Days after onset:99
Entered: 2014-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. J010569 / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-09-11
   Days after onset: 0
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: Immunisation
Preexisting Conditions: Renal transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1412GBR007653

Write-up: Information was received from Sanofi Pasteur MSD (E2014-12518) on 15-DEC-2014. This case was received from a HCP on 11-Dec-2014. This case is medically confirmed. A 71 year old female patient who had previously undergone a kidney transplant received an injection of ZOSTAVAX (batch number J010569, expiry 01-2015), route and site not reported, on 06-Jun-2014. On 11-Sep-2014, three months post vaccination, the patient died. No further information was reported.


VAERS ID: 569233 (history)  
Form: Version 1.0  
Age: 0.24  
Sex: Male  
Location: Foreign  
Vaccinated:2014-09-15
Onset:0000-00-00
Submitted: 2014-12-19
Entered: 2014-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB814A / 1 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA765AE / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Intussusception
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MU2014GSK023934

Write-up: This case was reported by a physician via sales rep and described the occurrence of intussusception in a infant male patient who received ROTARIX. On 21st June 2014, the patient received the 1st dose of ROTARIX (oral). In September 2014, 91 days after receiving ROTARIX, the patient experienced intussusception (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the intussusception was unknown. It was unknown if the reporter considered the intussusception to be related to ROTARIX. Follow up information was received on 5th December 2014 from a physician via a sales representative. The patient had no known medical history or concurrent illness. The patient''s date of birth was updated. The vaccination date was changed to 15th September 2014. The patient was vaccinated with 1st dose of ROTARIX (batch number AROLA765AE, expiry date July 2016). Concomitant products included INFANRIX HEXA given on 15th September 2014. In September 2014, less than a month after vaccination with ROTARIX, the patient experienced intussusception (serious criteria Fatal, hospitalisation and Life Threatening). On an unknown date, the outcome of the intussusception was fatal. The reported cause of death was intussusception. The reporter considered the intussusception to be related to ROTARIX.


VAERS ID: 562088 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-12-11
Onset:2014-12-11
   Days after vaccination:0
Submitted: 2014-12-22
   Days after onset:11
Entered: 2014-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / SANOFI PASTEUR L8304 / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J81984 / 1 UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014347925

Write-up: This is a spontaneous report received from the Regulatory Authority. Regulatory Authority report number 285002. A general practitioner (contactable through Regulatory Authority only) referred that a 67-year-old male patient received on 11Dec2014 a dose of PREVENAR 13 (Lot n. J81984 expiration date 31May2017) subcutaneous and INTANZA (Lot n. L8304-1, expiration date 30Jun2015) subcutaneous. The patient medical history and concomitant medications were not reported. The patient experienced cardiac arrest on 11Dec2014 after 90 minutes from vaccination. The emergency medical service was contacted. The patient died on 11Dec2014.


VAERS ID: 570893 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-12-22
Entered: 2014-12-24
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / SYR
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Gastrointestinal inflammation
SMQs:, Gastrointestinal nonspecific inflammation (broad), Ischaemic colitis (broad), Noninfectious diarrhoea (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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1412JPN009930

Write-up: Initial information has been received from a physician concerning an infant patient (gender unknown) who on an unspecified date was vaccinated with ROTATEQ mixture for internal use orally (lot number, dose and indication not reported). On an unspecified date, the infant patient was vaccinated with the concomitant medications: ACTHIB, injection via a parental route and PREVENAR 13, injection via a parental route at the same time. In 2014 (three weeks after ROTATEQ vaccination), the infant patient''s mother found the infant patient was worn out and she summoned an ambulance. The infant patient was sent to hospital B and was found already dead. On an unspecified date, autopsy was performed. From the result of autopsy, the inflammation in intestine was found. The cause of death was not reported. At the time of this report, the outcome of the inflammation in intestine was unknown. The reporter''s comment: from the results of autopsy, the inflammation in intestine was found, but the relationship to ROTATEQ was unknown. I though the infant death was not related to ROTATEQ. But the infant patient''s mother thought it may be caused by vaccines. From that, the information of hospital visit, contact or others was not received. The reporting physician did not assess the seriousness of the inflammation in intestine. The reporting physician felt that the infant death was not related to ROTATEQ. Upon internal review, it was considered that the relationship of infant death to ROTATEQ could not be ruled out. The reporting physician felt that the relationship between the inflammation in intestine and ROTATEQ was unknown. Additional information has been requested.


VAERS ID: 573037 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-29
Onset:2014-12-13
   Days after vaccination:14
Submitted: 2014-12-29
   Days after onset:16
Entered: 2014-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Blood pressure increased, Cardiac failure, Death, Ischaemia, Listless
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-13
   Days after onset: 0
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: Back pain; Pain in extremity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure diastolic, about 65-70; 2014, Blood pressure diastolic, 86; Blood pressure systolic, 120; 2014, Blood pressure systolic, 140
CDC Split Type: WAES1412JPN012542

Write-up: Initial information has been received from a patient''s family concerning a 80 years old female patient with the pain in the lower body, who on 29-NOV-2014 was subcutaneously vaccinated with PNEUMOVAX NP, injection (lot number, dose were not reported). Other concomitant medications included unspecified drugs, administered orally. On 29-NOV-2014 (Saturday), the PNEUMOVAX NP, was vaccinated. Afterwards, there was especially no side reaction. On an unspecified date in 2014, the patient experienced listless. On an unspecified date in 2014, the patient''s blood pressure was 140/86 (units not reported) which was higher than usual. The usual blood pressure was about 120/65-70. On 13-DEC-2014 (Saturday), the patient died while taking a bath at about 9-10 pm. The cause of death was cardiac failure. Information on the autopsy was not reported. At the time of the report, the outcomes of "listless" and "blood pressure was higher than usual" were unknown. Comment of the reporter: Considering the patient was an old aged person, I didn''t think death of the patient is vaccine related. However, I want to check the facts here. The patient had been healthy and did not have any chronic diseases. Nothing in particular was found at the health check. Pain reliever might have been administered due to a pain in the lower body. Ginseng etc. may also have been used. According to the coroner the patient probably died of ischemia trouble at about 9-10 pm. As the patient had been living alone, details are not understood. The patient was being contacted daily even in the daytime of 13-DEC-2014. The death cause is still being confirmed and the vaccine is considered as a cause. The reporter considered cardiac failure was serious due to death, but did not assess the seriousness of listless and "blood pressure was higher than usual". The reporter considered cardiac failure was related to PNEUMOVAX NP. The reporter did not assess the relationship of listless and "blood pressure was higher than usual" to PNEUMOVAX NP. Follow-up attempt was not made because the reporter did not wish to be contacted. Additional information is not expected due to no consent for follow up.


VAERS ID: 573091 (history)  
Form: Version 1.0  
Age: 0.13  
Sex: Male  
Location: Foreign  
Vaccinated:2014-12-11
Onset:2014-12-11
   Days after vaccination:0
Submitted: 2014-12-29
   Days after onset:18
Entered: 2014-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 3C5401 / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER K5385 / UNK MO / PO
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH J74331 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB097BB / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-13
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZA2014GSK040235

Write-up: This case was reported by a nurse and described the occurrence of death unexplained in a 7-week-old male patient who received ROTARIX (batch number AROLB097BB, expiry date unknown). Co-suspect products included PREVENAR (batch number J74331, expiry date unknown), Oral Polio vaccine (batch number K5385, expiry date unknown) and Hepatitis B vaccine (batch number 3C5401/0, expiry date unknown). On 11th December 2014, the patient received ROTARIX (oral), PREVENAR (unknown), Oral Polio vaccine (oral) and Hepatitis B vaccine (unknown). On 13th December 2014, 2 days after receiving ROTARIX, the patient experienced death unexplained (serious criteria death and GSK medically significant). On an unknown date, the patient experienced adverse event (serious criteria hospitalization). On an unknown date, the outcome of the death unexplained was fatal and the outcome of the adverse event was unknown. The patient died on 13th December 2014. The reported cause of death was unknown cause of death. It as unknown if the reporter considered the death unexplained and adverse event to be related to ROTARIX. Additional information received: A nurse reported that the patient was admitted on the same afternoon that the vaccines were given (cause not reported) and died on 13th December 2014 (unknown cause of death).


VAERS ID: 573181 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2014-12-01
Onset:2014-12-18
   Days after vaccination:17
Submitted: 2014-12-25
   Days after onset:7
Entered: 2014-12-30
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER A015C / 2 UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR K1256 / 3 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 13M02A / 3 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dyspepsia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-18
   Days after onset: 0
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: Trisomy 18; Ventricular septal defect; Patent ductus arteriosus; Pulmonary hypertension; Low birth weight baby
Allergies:
Diagnostic Lab Data: 01-DEC-2014, Body temperature, 36.9 Centigrade
CDC Split Type: 2014352897

Write-up: This is an initial spontaneous report from a contactable physician received from Agency under the regulatory authority report number V14100887. A 4-month-old female patient received on 01Dec2014 (at 14:50) the 3rd dose of PREVENAR 13 (Lot No. 13M02A, expiration date: 30Nov2016) subcutaneously at 0.5ml single dose, the 3rd dose of ACT-HIB (Lot No. K1256), and the 2nd dose of QUATTROVAC (Lot No. A015C), both subcutaneously at 1 DF (single dose) on 01Dec2014 (at 14:50). Medical history included ongoing trisomy 18, ongoing ventricular septal defect, ongoing patent ductus arteriosus, ongoing pulmonary hypertension, and low birth weight baby. Concomitant medications were not reported. Body temperature prior to the vaccinations on 01Dec2014 was 36.9 degrees Centigrade. Clinical course was as follow: Poor digestion of milk was seen over the past few days. On the morning of 18Dec2014, weak breathing was noted. At around 22:00 on 18Dec2014, the patient was found to experience respiratory arrest and was brought to the reporter''s hospital. The patient died on 18Dec2014. No information was provided whether autopsy was performed or not. The reporting physician classified the event ''respiratory arrest'' as serious due to fatal outcome and commented as follows: It was considered the event was due to underlying diseases of trisomy 18, ventricular septal defect and pulmonary hypertension, but involvement of the vaccinations could not be denied.


VAERS ID: 573327 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2014-12-16
Onset:0000-00-00
Submitted: 2014-12-30
Entered: 2014-12-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC

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: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA177936

Write-up: Initial report received from a healthcare professional (Pharmacist) on 22 December 2014. A patient, whose age, gender, medical history and concomitant medications were not reported, had received 0.5 ml of ACTHIB batch number, site of administration and dose in series was not reported, subcutaneously on 16 December 2014. On 20-Dec-2014, the patient was transported to the hospital. Patient''s corrective treatment and laboratory investigation was not reported. On an unknown date, the patient died. Documents held by sender: None.


VAERS ID: 573338 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:2014-12-22
Onset:0000-00-00
Submitted: 2014-12-31
Entered: 2015-01-02
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / 2 UN / IM

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: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA179362

Write-up: Initial report received from a healthcare professional (company representative) on 26 December 2014. A 03-month-old patient, whose gender, medical history and concomitant medications were not reported, had received 0.5 ml intramuscular second dose of IMOVAX POLIO, (batch number and site of vaccination not reported) and 0.5 ml intramuscular first dose of DTAP, (batch number and site of vaccination not reported), both on 22 December 2014. On 23 December 2014 at 03 hours, the patient was found dead. The cause of death was unknown. The local CDC preliminarily considered there was no relationship between the death and the two vaccines. Documents held by sender: none.


VAERS ID: 573517 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-11
Onset:2014-12-01
   Days after vaccination:20
Submitted: 2014-12-26
   Days after onset:25
Entered: 2015-01-05
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Malaise, Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT168563

Write-up: Case number PHHY2014IT168563, is an initial spontaneous report from a consumer (journalist) via company representative received on 23 Dec 2014. This report refers to an 84-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was in good clinical condition before the vaccination. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 11 Nov 2014. On an unknown date, a few days after vaccination, the patient experienced malaise and the patient hospitalized. The patient''s malaise seemed to be transitory. In Dec 2014, about a month after the vaccination, the patient''s general malaise worsened quickly and the patient had respiratory complications. The outcome of the events was fatal. The cause of death seemed to be respiratory complications. The medical staff had ordered an autopsy and investigational examination but the results were not available. The medical staff excluded the relationship between vaccination and the events. The patient''s family stated that the patient was in good condition before the vaccination. The patient condition had worsened after the vaccination followed by a sudden aggravation which required hospitalization. Seriousness of the events was reported as death and hospitalization and causality to be suspected to the administration of the vaccine.


VAERS ID: 560984 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-10
Submitted: 2015-01-12
   Days after onset:63
Entered: 2015-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Autopsy, Death, Hepatomegaly, Toxicologic test
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-10
   Days after onset: 0
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: PHHY2015IT002281

Write-up: Case number PHHY2015IT002281, is an initial spontaneous report from a consumer (journalist) via company representative received on 09 Jan 2015. This report refers to a 90-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. Despite the advanced age, the patient was very active and completely self-sufficient. He was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unknown date. Prior to the bedtime, the patient had not experienced any particular disorder. On 10 Nov 2014, 12 hours after vaccination, the patient died while he was sleeping during the night. After the patient died, the relatives of the patient''s observed an excessive swelling of the abdominal area and liver. The liver tissues were taken to perform toxicological examinations. It was reported that autopsy was performed; however the results were not reported. The outcome and seriousness of the events excessive swelling of the abdominal area and liver were not reported. Causality was not reported.


VAERS ID: 573674 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: Foreign  
Vaccinated:2013-09-04
Onset:2014-10-02
   Days after vaccination:393
Submitted: 2015-01-09
   Days after onset:99
Entered: 2015-01-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G79293 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Meningitis pneumococcal, Nuclear magnetic resonance imaging abnormal, Pneumococcal infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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:
Current Illness:
Preexisting Conditions: 32 weeks gestation, Premature birth
Allergies:
Diagnostic Lab Data: Blood culture (02Oct2014): pneumococcal infection serotype 19A with pneumococcal meningitis; MRI scan (date unspecified): revealed devastating brain injury with extensive mieningo-enc (multi focal).
CDC Split Type: 2015003967

Write-up: This is a spontaneous report from a contactable healthcare professional via the Agency. A 15-month-old female patient received as immunisation three doses of PREVENAR 13; first dose (batch/lot G79293, expiry date Mar2015) on 04Sep2013 at the age of 2 months, second dose (batch/lot G33994, expiry Apr2015) on 19Nov2013 at age of 4 months and booster dose (batch/lot H46986, exp Nov2015) on 07Aug2014 at age of 13 months. Relevant medical history included premature birth at 32 weeks gestation. The patients concomitant medications were not reported. On 02Oct2014 the patient experienced a pneumococcal infection serotype 19A with pneumococcal meningitis which was reported as a vaccination failure. The specimen was taken from a blood culture on 02Oct2014. It was unknown if the patient was in a risk group. An MRI scan performed on an unspecified date revealed devastating brain injury. The patient died on an unknown date. It was unknown if an autopsy was performed. No follow-up possible. No further information expected.


VAERS ID: 573678 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-12-27
Onset:0000-00-00
Submitted: 2015-01-10
Entered: 2015-01-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR K1326 / 4 RA / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 2015SA001413

Write-up: Initial unsolicited report received from pediatrician via our partner company on 06 January 2015. A 12-month-old male patient, whose concomitant medication was not reported had received 0.5 ml of booster dose (4th dose) of ACTHIB (batch number K1326) subcutaneously in right upper arm and a dose of INFLUENZA VACCINE (batch number, dose, dose in series, route and site of administration was not reported both on 27 December 2014. The patient had no underlying diseases, no concurrent condition, no historical condition, no history of adverse drug reaction and no allergy history. On 31-Dec-2014, the patient died at another hospital. According to the mother, the prosecutors said that there was no relationship between the vaccination and his death. Laboratory investigation and corrective treatment was not reported. Reporting physician''s seriousness assessment: Serious Reporting physician''s causality assessment: Not provided Documents held by sender: none.


VAERS ID: 573706 (history)  
Form: Version 1.0  
Age: 0.69  
Sex: Female  
Location: Foreign  
Vaccinated:2014-05-09
Onset:2014-11-21
   Days after vaccination:196
Submitted: 2015-01-09
   Days after onset:49
Entered: 2015-01-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G34370 / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacteraemia, Blood culture positive, Death, Developmental delay, Hypermobility syndrome, Pneumococcal infection
SMQs:, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: 21-NOV-2014, Blood culture, pneumococcal infection, serotype 19F
CDC Split Type: 2015003985

Write-up: This is a spontaneous report from a contactable healthcare professional via the Agency. A 14 months old female patient of an unspecified ethnicity received her first single dose of PREVENAR 13 (lot G33225) on 16Nov2013 when she was 2 months old. The second single dose was received on 09May2014 from lot G34370 when she was 8 months old. Relevant medical history and concomitant medications were not reported. On 21Nov2014, the patient experienced pneumococcal infection, serotype 19F which involved hospitalization. The specimen was taken from the blood culture on 21Nov2014. The patient was reported to be 14 month old at the time of infection. It was also noted that the patient also suffered from bacteraemia, developmental delay and wrist hypermobility and transferred from a hospital. The onset dates of these conditions had not been specified. On an unknown date, the patient died as a result of the pneumococcal infection. The outcomes of the other events prior to the patient death were unknown at the time of this report. No follow-up attempts possible. No further information expected.


VAERS ID: 573733 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-01-14
Entered: 2015-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, 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: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, toleration was not reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1501DEU003164

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR control# E2015-00044) on 09-JAN-2015. Case of fatal outcome was received from a healthcare professional on 07-Jan-2015. Case is medically confirmed. Case is linked with E2014-00045, -00046 and -00047 (same reporter, same vaccine, different reactions), with E2014-00048, -00049, -00050 and -00051 (same reporter, different vaccine, different reactions). A 16-year-old female patient received a second dose of GARDASIL (lot-no. not reported) on an unspecified date three to four years ago. Unspecified time later she developed a pulmonary embolism and died. It was unknown if the patient took oral contraceptives. First dose of GARDASIL was given on an unspecified date. Toleration was not reported.


VAERS ID: 573824 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-11-11
Submitted: 2015-01-16
   Days after onset:431
Entered: 2015-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
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: 2013-11-11
   Days after onset: 0
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: PHHY2015IT004173

Write-up: Case number PHHY2015IT004173 is an initial spontaneous report received from a consumer via lawyer on 12 Jan 2015. This report refers to an 85 years old female patient. She had a healthy life and followed a very strict diet. Her concomitant medications were not reported. She was vaccinated with AGRIPPAL (batch number: not reported) on an unknown date. It was reported that the patient suddenly died on 11 Nov 2013 after vaccination with AGRIPPAL. She was in good health before death. The health authority assessed the event as serious. The causality of the event was not reported.


VAERS ID: 573846 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-01-16
Entered: 2015-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Albumin urine present, Atrioventricular block complete, Blood creatine phosphokinase MB increased, Blood creatinine increased, Blood urea increased, Bradycardia, Brain natriuretic peptide increased, Bundle branch block left, Bundle branch block right, Cardiac arrest, Cardiac pacemaker insertion, Cardioversion, Chest X-ray abnormal, Complication of device insertion, Corynebacterium infection, Corynebacterium test positive, Cough, Culture throat positive, Death, Diphtheria, Dysphagia, Dyspnoea, Echocardiogram normal, Ejection fraction decreased, Electrocardiogram abnormal, Electrocardiogram normal, Gastrointestinal tube insertion, Glucose urine present, Gram stain positive, Haematemesis, Haematocrit decreased, Haemoglobin normal, Haemoptysis, Hypotension, Immunoglobulin therapy, Increased bronchial secretion, Liver function test normal, Lymphocyte percentage decreased, Monocyte percentage increased, Myocarditis bacterial, Neutrophil percentage increased, Nodal rhythm, Oropharyngeal pain, Pericardial effusion, Pharyngitis, Platelet count decreased, Pyrexia, Red blood cell sedimentation rate normal, Red blood cells urine positive, Supraventricular extrasystoles, Swelling, Tachycardia, Tonsillar haemorrhage, Tonsillar inflammation, Tricuspid valve incompetence, Troponin T increased, Ventricular extrasystoles, Ventricular tachycardia, White blood cell count increased, White blood cells urine positive
SMQs:, Torsade de pointes/QT prolongation (narrow), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Agranulocytosis (broad), Angioedema (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 (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Conduction defects (narrow), Supraventricular tachyarrhythmias (narrow), Ventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), 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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: A urinalysis showed 5-10 red blood cells per high-power field, 10-20 white cells count per high-power field, 2+ albumin and trace glucose. A throat swab Gram stain showed Gram-positive bacilli. A throat swab culture showed Corynebacterium Diphtheriae. The Elek test for detection of toxigenic Corynebacterium strain was positive. Blood creatine phosphokinase MB, 7.6 ng/mL; Blood creatinine, 1.0 mg/dL; Blood creatinine, 1.7 mg/dL; Blood pressure, 106/74 mmHg; Blood pressure, 90/50 mmHg; Blood pressure, 110/90 mmHg; Blood urea increased, 40 mg/dL; Body temperature, 37.5 degree C; Brain natriuretic peptide, 1236 ng/L; Cardiac index, 2.5 l/min; Cardiac ouput, 2 l/min; Chest X-ray, Confirmed the position of the pacemaker; Chest X-ray, Bilateral neck swelling; Echocardiogram, No significant ST segment changes; Ejection fraction, 8 percent; Ejection fraction, 45 percent; Ejection fraction, 55 percent; Electrocardiogram, Ectopic atrial rhythm; Electrocardiogram, Tip of the pacemaker in myocardium; Electrocardiogram, Normal sinus rhythm; Electrocardiogram, left bundle branch block; Electrocardiogram, junctional rhythm; Haemotocrit, 31.4 percent; Haemoglobin, 11.4 g/dL; Heart rate, 40-70 beats/min; Heart rate, 130 beats/min; Heart rate, 153 beats/min; Heart rate, 80 beats/min; Heart rate, 90 beats/min; Heart rate, 200 beats/min; Heart rate, 40-60 beats/min; Liver function test, Normal; Lymphocyte percentage, 12 percent; Monocyte percentage, 11 percent; Neutrophil percentage, 74 percent; Platelet count, 80,000 /mm3; Red blood cell sedimentation rate, Normal; Respiratory rate, 20 breath(s); Respiratory rate, 22 breath(s); Troponin T, 74 ng/mL; White blood cell count, 22,600 cells/mm3; White blood cell count, 30,300 cells/mm3
CDC Split Type: TH2015GSK005457

Write-up: This case was reported in a literature article and described the occurrence of death in a 9-year-old male patient who received Hepatitis B vaccine. Co-suspect products included BCG vaccine. On an unknown date, the patient received Hepatitis B vaccine (unknown) and BCG vaccine (unknown). On an unknown date, 9 years after receiving Hepatitis B vaccine, the patient experienced death (serious criteria death and GSK medically significant), cardiac arrest (serious criteria death and GSK medically significant), myocarditis bacterial (serious criteria death and GSK medically significant), corynebacterium diphtheriae infection (serious criteria GSK medically significant), dyspnea (serious criteria hospitalization), emesis bloody (serious criteria GSK medically significant), ventricular tachycardia (serious criteria GSK medically significant), third degree AV block (serious criteria GSK medically significant), fever, cough, sore throat, pharyngitis, neck swelling, dysphagia, tonsillar inflammation, tracheo-bronchial secretion excess, blood streaked sputum, tachycardia, bradycardia, hypotension, tricuspid regurgitation (serious criteria GSK medically significant), ectopic atrial beats, incomplete right bundle branch block, junctional rhythm, premature ventricular contractions and left bundle branch block. The patient was treated with Antibiotics (Drug Name Unknown), Acetaminophen, Normal Saline, ceftriaxone, diphtheria antitoxin, Penicillin G, cefotaxime, milrinone, methylprednisolone, Immunoglobulin, dobutamine and amiodarone. On an unknown date, the outcome of the death, cardiac arrest and myocarditis bacterial were fatal and the outcome of the corynebacterium diphtheriae infection, dyspnea, emesis bloody, ventricular tachycardia, third degree AV block, cough, pharyngitis, neck swelling, dysphagia, tonsillar inflammation, tracheobronchial secretion excess, blood streaked sputum, tachycardia, bradycardia, hypotension, tricuspid regurgitation, ectopic atrial beats, incomplete right bundle branch block, junctional rhythm, premature ventricular contractions and left bundle branch block were unknown and the outcome of the fever was recovering/resolving and the outcome of the sore throat was recovered/resolved. The reported cause of death was myocarditis bacterial, cardiac arrest and unknown cause of death. It was unknown if the reporter considered the death, cardiac arrest, myocarditis bacterial, corynebacterium diphtheriae infection, dyspnea, emesis bloody, ventricular tachycardia, third degree AV block, fever, cough, sore throat, pharyngitis, neck swelling, dysphagia, tonsillar inflammation, tracheobronchial secretion excess, blood streaked sputum, tachycardia, bradycardia, hypotension, tricuspid regurgitation, ectopic atrial beats, incomplete right bundle branch block, junctional rhythm, premature ventricular contractions and left bundle branch block to be related to Hepatitis B vaccine. Additional information: This case was reported in a literature article and it described the occurrence of diphtheric myocarditis in a 9-year-old male patient who had received an unspecified Hepatitis B vaccine and an unspecified Bacille Calmette-Guerin vaccine (manufacturers unknown). The patient had been born in a hospital where he had received the two vaccines at birth. The patient had been born via vaginal delivery with a birth weight of 2700 gr, and at the time of the event his weight was 22 kg (10th centile) and his height was 130 cm (50th centile). He had no known relevant medical history or history of close contact with sick people. He had not received any other vaccination. At the time of the event he was living with 9 relatives who received chemoprophylaxis with erythromycin for 10 days. No carriers were identified and the authors reported that no outbreak resulted from this event. No further information on the patient''s medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, at birth, the patient received an unspecified hepatitis B vaccine and an unspecified Bacille Calmette-Guerine vaccine (administration routes and sites unspecified; dosages unknown; batch numbers not provided). On an unspecified date, when the patient was 9 years old, he developed low-grade fever, cough and sore throat. He was seen in a rural clinic on the day of the onset and he was diagnosed with pharyngitis. After 3 days the fever had gradually declined and the sore throat had resolved. However his condition later worsened and he developed neck swelling, dysponea, harsh breathing sound and dysphagia; so he was taken to a local hospital by his parents on day 5 after onset. Upon examination at the local hospital his blood pressure was 110/90 mmHg, his heart rate was 153 bpm, temperature of 37.5 degree C, respiratory rate of 22 breaths/min and room air oxygen saturation of 75%. He was noted to have inflamed tonsils with white patches, inspiratory stridor and poor air entry without adventitious sounds. In view of this he was intubated at the local hospital and had copious amounts of white and bloody secretions suctioned from the tube. In addition to this, he had a nasogastric tube placed that revealed 20 mL of fresh blood and a substantial amount of coffee ground emesis. The patient was then referred to another hospital. On initial evaluation at that hospital, he was afebrile (37.5 degree C), tachycardic (130 bpm), with a normal respiratory rate (20 breaths/min) and normal blood pressure (106/74 mmHg). Upon examination during the admission he was reported to be fully alert, able to follow commands, move all his extremities equally well and open his eyes spontaneously. His pupils were equal, round and reactive to light with normal accommodation. Bilateral neck tissue swelling (soft, tender and without fluctuation or rash) and enlarged bleeding tonsils with white patches were noted. His lungs were bilaterally clear to auscultation. On the third day of admission the patient was asymptomatic with a normal blood pressure but he became bradycardic (80 bpm, electrocardiogram: ectopic atrial rhythm and incomplete right bundle branch block). He later developed a third-degree atrioventricular block with a rate of 40-70 bpm and hypotension (90/50 mmHg) that required the implementation of a temporary pacemaker. On the ten day of hospitalisation a follow-up ECG showed that the tip of the pacemaker had penetrated the myocardium and the patient had a moderate amount of pericardial effusion (approximately 200 mL of bloody pericardial fluid was drained through a percutaneous intrapericardial catheter). The pacemaker was removed and the patient remained in a junctional rhythm (40-60 bpm) but without further arrhythmias and hypotension. Nevertheless, the new onset of complete left bundle branch block was noted on day thirteen after admission, which according to the authors indicated ongoing conduction system damage from the diphtheria toxin. The patient later developed a ventricular tachycardia (200 bpm) that required repeated chemical and electrical cardioversion. Once normal sinus rhythm was recovered a minimal pericardial effusion and an ejection fraction of 45% were observed. The patient''s cardiac function deteriorated further on day sixteen after admission. Despite of intensive treatment he suffered an asystolic cardiac arrest and died. The authors reported that the suspected main cause of death was progressive fulminant myocarditis. It is unknown if a post-mortem was performed. Blood test performed at the rural hospital showed a leukocytosis (30,300 cells/mm3) and a high creatinine level (1.7 mg/dL). Once in the final hospital, his haemoglobin level was 11.4 g/dL, haematocrit was 31.4%, white cell count was 22,600 cells/mm3 (neutrophils 74%, lymphocytes 12% and monocytes 11%) and platelet count was 80,000/mm3. His urea nitrogen (40 mg/dL) and creatinine (1.0 mg/dL) were elevated on admission. The authors reported that his liver function tests and erythrocyte sedimentation rate were within normal limits. A urinalysis showed 5-10 red blood cells per high-power field, 10-20 white cells count per high-power field, 2+ albumin and trace glucose. In addition to this, his troponin T level was 74 ng/mL and creatine kinase-MB level was 7.6 ng/mL. His pro-brain natriuretic peptide was 1236 ng/L. A throat swab Gram stain showed Gram-positive bacilli. A throat swab culture showed Corynebacterium diphtheriae. The Elek test for detection on toxigenic Corynebacterium strain was positive. A chest radiograph showed bilateral neck swelling and patchy right lower lobe infiltration. The authors reported that an electrocardiogram and a echocardiogram performed on the day of admission showed a normal sinus rhythm at 90 bpm without significant ST segment changes a left ventricular ejection fraction of 55%, cardiac output of 2 L/min, cardiac index of 2.5 L/min/m2, mild tricuspid regurgitation, no chamber enlargement and no pericardial effusion. An electrocardiogram performed on the third day of admission showed an ectopic atrial rhythm (inverted P wave in lead II) and incomplete right bundle branch block. Chest radiography performed after the pacemaker insertion confirmed the position of the pacing catheter but a follow-up echocardiogram performed on the ten day of hospitalisation showed that the tip of the pacemaker had penetrated the myocardium and a moderate amount of pericardial effusion. An electrocardiogram performed after the pacemaker was removed and the effusion drained, showed a junctional rhythm with occasional premature ventricular complexes. Repeated echocardiogram 2 hours later showed no increase in the pericardial effusion. Another electrocardiogram showed a new complete left bundle branch block on day thirteen of hospitalisation and an echocardiogram performed after cardioversion was achieved revealed a minimal pericardial effusion with an ejection fraction of 45%. The ejection fraction had decreased by 8% on the final echocardiogram performed on day sixteen. The treatment initiated in the rural clinic consisted of an unknown oral antibiotic and acetaminophen. The patient also received a bolus dose of normal saline (20 mL/kg) and 2 g of ceftriaxone in the rural hospital before his transfer to the final hospital. Once there he was started on diphtheria antitoxin (120,000 units intravenously, after hypersensitivity testing), penicillin G (200,000 U/kg/day intravenously every 6 h), cefotaxime (150 mg/kg/day intravenously every 6 h) and milrinone. In addition to this, he also received Intravenous methylprednisolone (2 mg/kg/day) to treat the severe myocarditis; to which intravenous immunoglobulin (1 g/kg/day) was added on the third day of admission for the same indication. As mentioned above a temporary transvenous pacemaker was inserted at this point and set to 80 bpm to treat the atrioventricular block and the hypotension. The pacemaker was inserted via the right internal jugular vein with echocardiographic guidance, and the tip of the pacemaker was placed on the right ventricular apex. However it had to be removed on the ten day as the tip had penetrated the myocardium causing a pericardial effusion that had to be drained via a percutaneous intrapericardial catheter. Dobutamine and amiodarone were used to attempt a chemical cardioversion on day thirteen of the admission but it failed; and repeated synchronised electrical cardioversion had to be used instead (first attempt 1 J/kg; second attempt 2 J/kg). The patient also received the maximum dose of milrinone and dobutamine on the sixteen day before his demise. The outcome of the event was fatal. The authors did not comment on any causal relationship between the vaccines administered and the event. The authors concluded that "In general, the therapy for myocarditis during the acute phase in children includes supportive care to maintain haemodynamic stability and adequate systemic perfusion. In fulminant cases mechanical support of the circulation with extracorporeal membrane oxygenation or a ventricular assist device followed by cardiac transplantation may be necessary. Children with diphtheritic myocarditis are challenging to manage. Often, several organ systems are affected by the infection and toxin. Disease prevention through vaccination and early identification/treatment are the major keys in reducing the morbidity and mortality of this particular disease".


VAERS ID: 573855 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-12-01
Submitted: 2015-01-19
   Days after onset:414
Entered: 2015-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Autopsy, C-reactive protein increased, Computerised tomogram normal, Death, Fibrin D dimer, Glomerulonephritis, Haematocrit decreased, Haemoglobin decreased, International normalised ratio normal, Myocardial ischaemia, Neutrophil percentage increased, Paraparesis, Renal necrosis, Renal vasculitis, Toxicologic test normal, Urinary tract infection, Urine analysis abnormal, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Other ischaemic heart disease (narrow), Vasculitis (narrow), Renovascular disorders (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-29
   Days after onset: 28
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: NORVASC; LOSEC; RIVOTRIL
Current Illness: Unknown
Preexisting Conditions: Hypertension; Parkinson''s disease; Prostate cancer; Cancer surgery
Allergies:
Diagnostic Lab Data: 12/28/2013, C-reactive protein, 153; 12/28/2013, Haematocrit, 37.3%; 12/28/2013, Haemoglobin, 12.2; 12/28/2013, International normalised ratio, 1.15; 12/28/2013, Neutrophil count, 89%; 12/28/2013, White blood cell count, 12900
CDC Split Type: GR2015005546

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of paraparesis in a 83-year-old male patient who received Influenza vaccine. The patient''s past medical history included hypertension, Parkinson''s disease, prostate cancer and cancer surgery. Concomitant products included NORVASC, LOSEC and RIVOTRIL. In November 2013, the patient received Influenza vaccine. On 1st December 2013, 5 days after receiving Influenza vaccine, the patient experienced paraparesis (serious criteria hospitalization, GSK medically significant and other). On an unknown date, the outcome of the paraparesis was fatal. The patient died on 29th December 2013. The reported cause of death was myocardial ischemia. An autopsy was performed. The autopsy determined cause of death was myocardial ischemia. The reporter considered the paraparesis to be probably related to Influenza vaccine. Regulatory authority verbatim: Case 20130450 [physician, serious]. Initial report: An 83 year old man received an influenza vaccine of unknown brand name on an unknown date. On 1-DEC-2013, the patient presented paraparesis, probable Guillain Barre. The patient died on 29-DEC-2013. Follow up with the physician that reported the event: The patient was hospitalized on 28-DEC-2013 due to vomiting and weakness that had started 3 days earlier. One month earlier he had been vaccinated against influenza (the brand name of the vaccine was not known even to the patient). Five days after the vaccination the patient started to present paraparesis symptoms. On admission to hospital, the patient was subjected to computerized tomography of the lumbar area without any pathological findings of spinal cord compression. Blood test results: HCT: 37.3%, Hgb: 12.2, WBC 12900 (89% Neutrophils), INR 1.15, D-dimers: 1.6, CRP 153, Urine test results: pyosphairia (probably urinary tract infection, afebrile). TAZOCIN treatment was initiated immediately but the patient died on 29-DEC-2013. The physician considered it as outstanding that the patient went to hospital 25 days after the presentation of paraparesis symptoms although these symptoms started 5 days after the vaccination. Concomitant medicines included NORVASC, LOSEC and RIVOTRIL. The patient''s medical history included Parkinson''s disease and hypertension. Forensic autopsy report received: Date of death: 29-DEC-2013, time of death: 06:31 a.m. The death occurred as a result of recent myocardial ischemia on the background of nectrozing kidney vasculitis and glomerulonephritis. Toxicological laboratory results received: without findings. The patient had also a history of prostate cancer surgery. Committee causality assessment received: The reported adverse reaction is probably related to the vaccine.


VAERS ID: 574100 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-25
Onset:2014-12-03
   Days after vaccination:8
Submitted: 2015-01-28
   Days after onset:56
Entered: 2015-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA963AA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Necrotising colitis
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal ulceration (narrow), Ischaemic colitis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amikacin; atropine; benzylpenicillin; caffeine citrate; cefotaxime; fentanyl; flucloxacillin; furosemide; gentamicin; ketamine; potassium chloride; phytomenadione; poractant alfa; sodium acid phosphate; sodium chloride; spironolactone; suxa
Current Illness: Unknown
Preexisting Conditions: Growth retardation; Low birth weight baby, 514g; Premature baby
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2015008460

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of necrotizing enterocolitis in a 26-week-old male patient who received ROTARIX (batch number AROLA963AA, expiry date unknown). The patient''s past medical history included growth retardation, low birth weight baby (514g) and premature baby. Concomitant products included amikacin, atropine, benzylpenicillin, caffeine citrate, cefotaxime, fentanyl, flucloxacillin, furosemide, gentamicin, ketamine, potassium chloride, phytomenadione, poractant alfa, Sodium Acid Phosphate, sodium chloride, spironolactone and suxamethonium. On 25th November 2014, the patient received ROTARIX (oral). On 3rd December 2014, 7 or 8 days after receiving ROTARIX, the patient experienced necrotizing enterocolitis (serious criteria death and GSK medically significant). On 4th December 2014, the outcome of the necrotizing enterocolitis was fatal. The patient died on 4th December 2014. The reported cause of death was necrotizing colitis. It was unknown if the reporter considered the necrotizing enterocolitis to be related to ROTARIX. Regulatory authority verbatim: Developed necrotising enterocolitis 7 days post vaccination. This baby was an extremely growth restricted 26 week infant who had previously had Klebsiella sepsis. In view of his growth restriction and prematurity, he was at high risk of developing necrotising enterocolitis. It is likely the timing of the vaccine was coincidental; however, he did develop fulminant necrotising enterocolitis 7 days post vaccination, hence reporting.


VAERS ID: 574143 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-10-14
Onset:0000-00-00
Submitted: 2015-01-29
Entered: 2015-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Acute hepatic failure, Blister, Blood bilirubin increased, Confusional state, Death, General physical health deterioration, Herpes zoster, Immunoglobulin therapy, Influenza like illness, Injection site rash, Intensive care, Lethargy, Malaise, Mechanical ventilation, Multi-organ failure, Pyrexia, Rash, Rash vesicular, Respiratory failure, Varicella virus test positive, Varicella zoster virus infection, Viral test positive
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Lymphoma; 04/2014, rituximab, Chronic lymphocytic leukaemia; 04/2014, fludarabine phosphate, Chronic lymphocytic leukaemia; 04/2014, cyclophosphamide, Chronic lymphocytic leukaemia
Allergies:
Diagnostic Lab Data: Blood bilirubin, very high, increased; Bronchoalveolar lavage, initially positive for varicella zoster virus; Bronchoalveolar lavage, became negative for varicella zoster virus; Laboratory test, vesicle fluid confirmed clinical imp. of v. zoster; Viral test, positive for shingles vaccine
CDC Split Type: WAES1501GBR010409

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control #E2015-00473) on 26-JAN-2015. Initial case received on 21-Jan-2015 from health authority. GB-MHRA ADR 22824299. The case is medically confirmed as it was reported by a physician. A 79 year old male patient, with medical history of lymphoma, received an injection of ZOSTAVAX (batch number K00514, invalid) intramuscularly in the right deltoid, dose in series not reported, on 14-Oct-2014. On an unreported date, 2 weeks after the vaccine, the patient experienced flu like symptoms and lethargy and was unwell. On 19-Nov-2014, the patient was admitted to hospital with rash, consistent clinically with varicella zoster virus infection, was febrile and slightly confused but had no respiratory symptoms. Rash initially developed around the injection site on right deltoid but then developed widespread vesicles. On admission, the patient was treated with high dose of intravenous aciclovir. Subsequent vesicle fluid analysis confirmed the clinical impression of varicella zoster virus. He continued to develop new skin lesions over the next few days but remained clinically stable. On 24-Nov-2014, the patient rapidly deteriorated with respiratory failure requiring transfer to intensive care and invasive ventilation. With the increased doses of intravenous aciclovir and intravenous immunoglobulin the patient received, his skin became clear and subsequent bronchoalveolar lavage which had initially been positive for varicella zoster virus became negative. Despite this, the patient continued to deteriorate. He was extubated and briefly improved. For a short duration he was able to communicate with his family before deteriorating again. On an unreported date, the patient developed acute liver failure with a very high bilirubin which was already unexplained. On 14-Dec-2014 the patient died from multi-organ failure. The patient was treated with cyclophosphamide, fludarabine and rituximab chemotherapy until Apr-2014 for chronic lymphocytic leukemia that was why the patient was known in haematology department. The reporter had confirmation from colleagues in virology that the strain of varicella zoster virus identified was that of the shingles vaccine and therefore. The case was reported to agency. At the time of reporting, the patient had recovered from varicella-like rash and varicella zoster and he had not recovered from acute liver failure, confusion, fever, flu like symptoms, lethargy, respiratory failure and unwell. On 14-Dec-2014, the outcome of multi-organ failure was fatal. The case was considered as serious due to the patient''s death and hospitalisation.


VAERS ID: 574453 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-01-29
Entered: 2015-01-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

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: PHHY2015IT010210

Write-up: Case number PHHY2015IT010210 is an initial spontaneous report from lay press (journalist) on 26 Jan 2015. This report refers to a 92-year-old male patient. He was vaccinated with FLUAD (batch number: not reported) on an unknown date. On an unknown date, after vaccination the patient died (reason unspecified). It was reported that autopsy performed to the patient stated that there was no causal relationship between the death and vaccine administration.


VAERS ID: 574454 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-01-29
Entered: 2015-01-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

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: PHHY2015IT010208

Write-up: Case number PHHY2015IT010208, is an initial spontaneous report from a consumer (journalist) received on 26 Jan 2015. This report refers to a 70-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUAD (batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient died. The result of the autopsy performed revealed that there was no causal relationship between the death and FLUAD.


VAERS ID: 739901 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2015-01-07
Onset:2015-01-11
   Days after vaccination:4
Submitted: 2015-02-03
   Days after onset:23
Entered: 2015-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K009635 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Antibody test negative, Aspiration, Blood calcium increased, Blood culture positive, Blood potassium increased, Blood potassium normal, Bradycardia, Catheter culture positive, Central venous catheterisation, Compartment syndrome, Coombs direct test, Coombs direct test negative, Crying, Culture positive, Cyanosis, Death, Diarrhoea, Discomfort, Endotracheal intubation, Enterocolitis, Escherichia test positive, Faeces discoloured, Fatigue, Flatulence, Gastric fluid analysis abnormal, Gastrointestinal necrosis, Gastrointestinal tube insertion, Haemorrhage, Hypercalcaemia, Hyperkalaemia, Laparotomy, Livedo reticularis, Mucous stools, Norepinephrine increased, Oxygen saturation decreased, Packed red blood cell transfusion, Pallor, Peripheral ischaemia, Regurgitation, Resuscitation, Staphylococcus test positive, Tachycardia, Transfusion, Ultrasound scan normal, Ultrasound skull, Urine output decreased, Vena cava thrombosis, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Hypertension (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-12
   Days after onset: 1
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: CEBESINE; MYDRIATICUM; ALDACTONE; UVESTEROL-D; SYNAGIS; BENPANTHEN; EMLA; phytonadione; leucovorin calcium
Current Illness: Fundoscopy; Exposure to communicable disease
Preexisting Conditions: Bronchopulmonary dysplasia; Premature baby
Allergies:
Diagnostic Lab Data: Cytobacteriological exam of gastric fluid (05-JAN-2015): sterile culture; Plain abdomen radiography (January 2015): pneumatosis particularly on the right hypochondrium, and no pneumoperitoneum. Major air distension, expelling the diaphragm. Marked gastric distension. Plain abdomen radiography (January 2015) (2 PM): second plain abdomen radiography as the distension increased. There was still no pneuoperitoneum. No perforation. Plain abdomen radiography (January 2015): signs of enterocolitis. Trans-fontanel ultrasound (January 2015): no intraventricular haemorrhage. High Frequency Oscillatory pressure (January 2015): Ventilation improved, which led to a decrease of High Frequency Oscillatory pressure. Hemodynamic (January 2015): the examination was very difficult, due to very significant gaseous distension. It did not show any thrombosis but the vessels were not seen very well. The renal arteries seen were perfused, the aorta seen showed no thrombosis. Probable thrombosis of the mesenteric artery. Blood pressure (12-Jan-2015): low with Mean arterial pressure inferior to 20. Filling of 30 cc physiological serum then 20 ml of albumin. Heartbeat (January 2015): slowed down; ventilation tube cytobacteriological exam (12-JAN-2015): polymorphous flora Enterococcus faecalis Staphylococcus Epidermidis. Urinary tract catheter cytobacteriological exam (12-JAN-2015): low Escherichia coli type K1. Mean arterial pressure (January 2015): was at 23. Citrated blood hemostasis (January 2015): no apparent coagulum. 01/11/2015, Anti-erythrocyte antibody, negative not provided, Negative; 01/12/2015, Autopsy, digestive necrosis (viral or bacterial infection); 01/12/2015, Autopsy, diffuse thrombotic microangiopathy; 01/11/2015, Blood culture, peripheral aerobia blood culture: Staph Epidermidis; 12/04/2014, Blood potassium, 3.8 mmol/l; 01/11/2015, Blood potassium, 6.6 mmol/l; 01/12/2015, Blood potassium, 11.6 mmol/l; 01/12/2015, Blood pressure, low with Mean arterial pressure inferior to 20 not provided; 01/2015, Blood pressure, unmeasurable blood pressure not provided; 01/2015, Blood pressure, decreasing (after decompression) not provided, Decreased; 01/11/2015, Blood test, hypercalcemia not provided; 01/11/2015, Coombs direct test, negative not provided, Negative; 01/11/2015, Culture, E. Coli type K1, Enterococcus faecalis N/A; 01/02/2015, Femoral pulse, weak; 01/11/2015, Gastric fluid analysis, few Cocci Gram positive, a lot of Cocci Gram - N/A; 01/11/2015, Gastric fluid analysis, few leukocytes, erythrocytes, epithelial cells N/A; 01/2015, Haemodynamic test, did not show any thrombosis; 01-2015, Heart rate, Deep bradycardia at 60/min/min; 01/2015, Heart rate, progressively slowed down/min; 01/2015, Norepinephrine increased, increasd not provided, Increased
CDC Split Type: WAES1502FRA000132

Write-up: Information had been received from Sanofi Pasteur MSD (SPM) (manufacturer # E2015-00580) on 30-JAN-2015. Case received from the Health Authorities on 27-Jan-2015 under the reference number RE20150080: A female patient aged 37 amenorrhea weeks plus 3 (weight 2.480 kg) died from acute enterocolitis on 12-Jan-2015 at 4 AM 37, 4 days after she had received a dose of ROTATEQ, (batch number K009635) on 07-JAN-2015 and one day after receiving a dose of VZV human immunoglobulin (VARITECT, batch number B796323) on 10-Jan-2015. The infant was born premature at 25 amenorrhea weeks due to pre-eclampsia and her weight at birth was of 606g. She also had a medical history of bronchopulmonary dysplasia. She had potentially been exposed to varicella in the week from 5 to 11-Jan-2015. On 10-Jan-2015 at 3 PM, she had received an injection of VZV human immunoglobulin VARITECT, (batch number B796323) 2.5 ml, i.e. 45 IU on 1h30. As of 11-Jan-2015 at 7 AM, her state deteriorated regarding the digestive level, with the occurrence of regurgitation, bloated stomach and discomfort. Her condition rapidly deteriorated and led to a fulminating enterocolitis from which the infant died on 12-Jan at 4h37. The infant was concomitantly taking at least since 01-Jan-2015 UVESTEROL D 1 dose n degree 1 per day and ALDACTONE 7 mg OAD. On 02-Jan-2015, her femoral pulses were weak. The abdomen was supple although a little bloated. Cares of the seat with BEPANTHEN on 01-Jan. EMLAPATCH Notion of SYNAGIS. Since that date, the infant was exclusively given preterm milk. On 04-Jan-2015, a thickener (MAGIC MIX) was added. On 05-Jan-2015, cytobacteriological exam of gastric fluid showed sterile culture at 48h. On 07-Jan-2015, the patient was given vitamin K1 2 mg per OS, calcium folinate 1.2 ml per OS, MYDRIATICUM 1 drop every 1/4h during one hour and CEBESINE 1 drop in each eye for fundoscopy. On the same day, she was administered a dose of ROTATEQ (batch number K009635, expiry date March 2016). On 08-Jan-2015: Calcium Folinate 1.2 ml. Stools were normal. Thickener MAGIC MIX was changed for GUMILK. On 10-Jan-2015, she was administered VARITECT via peripheral venous route due to varicella exposure within the service where the infant was taken care of. Blood pressure was supervised before, during and after the administration. The patient had no respiratory distress nor hemodynamic instability. She had not received any transfusion previously. At 7 PM 20: the infant experienced significant gas, pushed, was uncomfortable and had one loose stool. She was infused on the left foot. Blood pressure was correct. In the night from 10 to 11-Jan-2015, the patient experienced bradycardia followed by desaturation when breastfed at 9 PM. Then was stable for the rest of the night. The abdomen was supple, she experienced several regurgitations, no stool. At times the baby did not seem comfortable. She was wriggling a lot. She was lied down on the belly at 6 AM. On 11-Jan-2015: one stool in the morning, which was painful. Abdomen sensitive on palpation, a bit bloated, numerous regurgitations. Patient cried a lot, the skin was pale and then greyish. Patient was tired. At 10h: bloated abdomen, regurgitations, the infant was grey. On examination the child was contracted and whining, and cutaneous coloration time was of 3 to 4 seconds. The infant was admitted to resuscitation service for enterocolitis. On arrival, the abdomen was extremely loosened and non depressible. The distension increased, the infant was whining, oxygen saturation was at 80%. She was quickly intubated. Nasogastric tube was inserted by low suction which provided red blood. (On arrival she regurgitated a lot by the nose and by the mouth: significant aspiration). Aspiration of the gastric fluid provided 200 ml of blood and milk. Treatment by cefotaxime (11 and 12-Jan), gentamicin (11-Jan), FLAGYL on 11 and 12-Jan, vancomycine (11 and 12-Jan). Two fillings of 40 cc physiological serum. Plain abdomen radiography showed pneumatosis particularly on the right hypochondrium, and no pneumoperitoneum. Major air distension, expelling the diaphragm. Marked gastric distension. 12 AM: clinical deterioration: the legs were highly marbled. The patient was given dobutamine. Filling with VIALEBEX, High Frequency Oscillatory Ventilation, SUFENTA, bicarbonate 42 per thousand, plasma, erythrocyte pellet were given. Trans-fontanel ultrasound showed no intraventricular haemorrhage. 2 PM: second plain abdomen radiography as the distension increased. There was still no pneumoperitoneum. No perforation. Deep bradycardia at 60/min. External cardiac massage during 10 min: adrenaline, ISUPREL, calcium gluconate and salbutamol were given. Kalemia at 6.6: infusion of insulin and glucose 30%, in the event of an intestinal necrosis leading to hyperkalemia. Noradrenaline (Mean arterial pressure at 37). 3 PM 15: another deep bradycardia: adrenalin, ISUPREL, salbutamol and calcium gluconate. Continuous ISUPREL was added. 4 PM 30: compartment syndrome was still present with discomfort on the venous return a little more stable from a general standpoint. 5 PM 30: ISUPREL was stopped. Dobutamine was progressively decreased considering a tachycardia at 180. The bloated abdomen was still not depressible. Mucoid stools white on arrival. Areactive since the sedated intubation with SUFENTANIL. Legs and pelvis purple-black at 20 minutes. Hypercalcemia and hyperkalemia. 6 PM: a little more stable. Upper hemibody more pink. Lower limbs were highly cyanosed. There was no diuresis. The infant was slightly reactive. Albumin at 20%, LASILIX. Insulin and glucose 30% still given. 6 PM 35: infant whining, pale and marbled. 8 PM 15: abdominal compartment syndrome with probable inferior vena cava thrombosis. Plain abdomen radiography showed signs of enterocolitis. Transverse laparotomy report: Laparotomy with a retractor. Digestive tract was drained by Alexis retractor. The infant was put under general anaesthesia, in a supine position. Sus-ombilical transverse incision. Careful opening of the peritoneum. Exteriorisation of the small intestine, which presented with diffuse enterocolitis lesions. Alexis retractor was fitted. Improvement of the ventilation parameters. Diagnosis: enterocolitis, abdominal compartment syndrome, lower limbs ischaemia. SUFENTA 2 gamma and TRACRIUM 1 mg were administered for general anesthesia of decompressive laparotomy. 9 PM 30: good tolerance to surgery (CELOCURINE and SUFENTA). Blood pressure after the decompression was decreasing: filling, albumin, increase of noradrenaline and dobutamine. Ventilation improved, which led to a decrease of High Frequency Oscillatory pressure. Hemodynamic work-up was performed but the examination was very difficult, due to very significant gaseous distension. It did not show any thrombosis but the vessels were seen very well. The renal arteries seen were perfused, the aorta seen showed no thrombosis. Probable thrombosis of the mesenteric artery. Unfractionated Heparin was initiated. Salbutamol and insulin were administered, infusion was performed. 10 PM 30: lower limbs were still highly cyanosed. There was no diuresis. Mean arterial pressure was at 23. The small intestine was black. 11 PM: Dopamine was added. QRS complexes tended to widen: Salbutamol. Heparin was stopped as there was blood in the digestive tract and in T. Bleeding resumed at the level of the central venous catheter puncture. On the same day, ESMERON, DIPRIVAN, etomidate, atropine, HYPNOVEL, Ketamine, sodium bicarbonate, calcium chloride, magnesium sulphate and MOPRAL were prescribed. 12-Jan-2015: blood pressure was low with Mean arterial pressure inferior to 20. Filling of 30 cc physiological serum then 20 ml of albumin. Dobutamine was increased and Dopamine was initiated. Packed red cells and plasma. 1 AM: noradrenaline was increased. Blood pressure was still low. A few drops of urine. As there was no urine, the infant was given LASILIX as of 3 AM. 3 AM 30: heartbeat slowed down, unmeasurable blood pressure. 4 Am: heart rate progressively slowed down. A further deep bradycardia. External cardiac massage. Adrenaline, calcium gluconate, salbutamol, bicarbonate: heart rate improved then progressively slowed down. All in all: major ionic disturbance related to an intestinal necrosis, intestine wholly necrosed. 4 AM 37: death of the infant. Autopsy diagnosis was asked for major hyperkalaemia on extended intestinal necrosis in the context of an acute enterocolitis with probable thrombosis of the inferior vena cava. Autopsy was performed on 12-Jan, revealing a diffuse thrombotic microangiopathy with extended intestinal necrosis, possibly due to viral or bacterial infection. Further work-up: 11-Jan-2015: peripheral aerobic blood culture was positive: monorphic flora Staphylococcus Epidermidis (antibiogram performed but result not provided, probable contaminant). Cytobacteriological exam of gastric fluid showed few leukocytes, erythrocytes and epithelial cells, flora containing few Cocci Gram positive and numerous Cocci Gram negative. Culture showed polymorphous flora E. Coli type K1 Enterococcus faecalis. Citrated blood hemostasis: no apparent coagulum. Search of anti-erythrocyte antibodies: direct antiglobulin test screening negative. The screening was negative. 12-Jan-2015: ventilation tube cytobacteriological exam: polymorphous flora Enterococcus faecalis Staphylococcus Epidermidis, urinary tract catheter cytobacteriological exam: low Escherichia coli type K1. 14-Jan-2015: search for E. Coli pathogenicity factors in the gastric fluid: absence of EAE, STX1 and STX2 genes. Absence of detection of PCR inhibitors. Biology: 04-Dec-2014: Blood potassium at 3.8; 11-Jan-2015: Blood potassium at 6.6; 12-Jan-2015: Blood potassium at 11.6. The Health Authorities considered ROTATEQ and VARITECT as suspect and assessed the causal relationship between the reported reactions and the suspect products as C1 S1 I1 according to the method of assessment. The Health Authorities considered CEBESINE and Mydriaticum as suspect medication and assessed the causal relationship between the reported reactions and the suspect products as not applicable according to the method of assessment. The Health Authorities specified that "causality was assessed without being detrimental to the findings of any investigations which might be performed in the context of legal or out-of-court procedures for compensation".


VAERS ID: 574611 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-06-06
Onset:2014-11-11
   Days after vaccination:158
Submitted: 2015-02-05
   Days after onset:86
Entered: 2015-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. J010569 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Contraindication to vaccination, Death, Incorrect route of drug administration
SMQs:, Medication errors (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2014-11-11
   Days after onset: 0
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: Amlodipine; amoxicillin; aspirin; atorvastatin; prednisolone; ramipril; ranitidine
Current Illness: Immunisation; Drug hypersensitivity; Hypertension
Preexisting Conditions: Organ donor; erythromycin, Drug hypersensitivity; tacrolimus, Drug interaction; clarithromycin, Drug interaction
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1502GBR001390

Write-up: Information has been received from a business agreement partner Sanofi Pasteur MSD (SPM) (MFR# GB-1577272925-E2015-00694) on 03-FEB-2015. This case involving medication error was received from the health authority on 29-Jan-2015. Ref GB-MHRA-ADR 22837666. This case is medically confirmed. A 70 year old female received an injection of ZOSTAVAX (batch number and lot number J010569, expire date 31-JAN-2015), IM, site not reported, on 06-Jun-2014. On 11-Nov-2014, five months post vaccination, the patient died. The patient had a history of hypertension and donor renal transplant. The patient experienced a drug interaction with clarithromycin and tacrolimus, and the patient had a drug allergy to erythromycin. The patient was taking concomitant amlodipine 10mg, amoxicillin 500mg, aspirin 75mg, atorvastatin 40mg, prednisolone 5mg, ramipril 2.5mg, and ranitidine 300mg for unknown indications. The reporter stated that it was not known whether the vaccine was a contributing factor and the cause of death was unknown. The reporter stated that the patient should not have received the vaccine as she had received a kidney transplant. The reporter considered the events to be serious due to hospitalisation and life threatening. Upon internal review the company also coded death, incorrect route of vaccination and medication error and added the serious criterion of death.


VAERS ID: 574665 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-12-04
Onset:2014-12-07
   Days after vaccination:3
Submitted: 2015-02-05
   Days after onset:60
Entered: 2015-02-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Circulatory collapse, Death, Resuscitation
SMQs:, Anaphylactic reaction (narrow), 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), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-07
   Days after onset: 0
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: Foster care
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2015GSK013930

Write-up: This case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a 13-year-old female patient who received CERVARIX. Concurrent medical conditions included foster care. Concomitant products included DTPa-IPV. On 4th December 2014, the patient received CERVARIX (unknown) .5 ml. On 7th December 2014, 3 days after receiving CERVARIX, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and collapse circulatory (serious criteria death and GSK medically significant). The patient was treated with non-drug therapy (Cardiopulmonary Resuscitation). On an unknown date, the outcome of the unknown cause of death and collapse circulatory were fatal. The patient died on 7th December 2014. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and collapse circulatory to be related to CERVARIX. Additional information was provided: The subject was living with a foster family (foster care). On 4 November 2014 the subject was vaccinated with an unspecified BOOSTRIX Polio (GSK) or REPEVAX (Sanofi Pasteur MSD). On 4 December 2014 the subject received an unknown dose of CERVARIX. On 7 December 2014, while the subject performed at a Christmas market, the subject collapsed. Immediately cardiopulmonary resuscitation (CPR) was performed by two physicians who visited the Christmas market. An emergency physician was called and the subject was hospitalised. Despite of another course of cardiopulmonary resuscitation (CPR) in the hospital the subject had to be declared dead. At the moment the cause of death was unknown. The deceased subject was transferred to an institute of forensic medicine. It was unknown whether an autopsy has been performed.


VAERS ID: 574707 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-01-31
Entered: 2015-02-09
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Antibody test abnormal, Autopsy, Biopsy brain abnormal, Blood electrolytes normal, Blood glucose normal, C-reactive protein normal, Cardiac arrest, Cerebellar ataxia, Conjunctivitis, Death, Encephalitis, Febrile convulsion, Hyperreflexia, Leukocytosis, Liver function test normal, Lyssavirus test positive, Pyrexia, Renal function test normal, Strabismus, Vomiting, White blood cell count abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (broad), 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), Dementia (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Vasculitis (broad), Conjunctival disorders (narrow), Ocular infections (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Immunoglobulin equine anti-rabies
Current Illness: Animal bite, in the forehead; Wound
Preexisting Conditions: Suture insertion, bite mark sutured on the front of his forehead near the left eyebrow, which measured 3cm x 4 cm; Wound treatment
Allergies:
Diagnostic Lab Data: Antibody test, Abnormal, Biopsies of cerebral cortex, cerebellum, hippocampus and medulla were positive for rabies antigen on fluorescent antibody technique and diagnostic confirmation of rabies encephalitis was made; Blood electrolytes, Normal; Blood glucose, Normal; Body temperature, 39 degrees C, High; C-reactive protein, Normal; Liver function test, Normal; Renal function test, Normal; White blood cell count, Abnormal, Neutrophilic leucocytosis
CDC Split Type: PHHY2015TN010823

Write-up: Case number PHHY2015TN010823 is an initial literature report received on 28 Jan 2015. The author discussed about a case of a child who presented with rabies encephalitis and died despite rabies post exposure prophylaxis (RPEP). This report refers to a 6 years old male patient. His medical history and concomitant medications were not reported. He was bitten by a stray dog on an unknown date on his forehead. RPEP was started on the same day he was bitten. He received a maximum dose of equine rabies immunoglobulin (ERIG, other manufacturer, batch number: not reported) 40 UI/kg into the wound and the rest intramuscularly into the deltoid region on day 0 after cleaning the wound. He also received 4 doses of RABIPUR (batch number: not reported) intramuscularly into the deltoid region on days 0, 3, 7 and 14 following WHO guidelines (ESSEN regimen + ERIG). The vaccine and ERIG were not out of date and were correctly kept at 4 to 8 degree Celsius before using. ERIG and vaccine were administered in different arms. Wound suture was performed on day 0 after ERIG administration. The child had presented 3 days before admission to the department with vomiting and fever, but without hydrophobia or hypersalivation. He was transferred from a regional hospital to the department for febrile seizure (17 days after dog bite). He was healthy and had no immunosuppressive disease or treatment. On admission he was febrile with a body temperature of 39 degree Celsius. He had conjunctivitis. There was a bite mark sutured on the front of his forehead near the left eyebrow, which measured 3cm x 4 cm. On neurological examination, the child had strabismus and was agitated. He had cerebellar ataxia and his reflexes were brisk in the lower limbs. There were no signs of respiratory or cardiac failure. Laboratory investigations revealed neutrophilic leucocytosis, normal C-reactive protein, blood glucose, electrolytes, liver and renal function tests. Herpes encephalitis was discussed because of it frequency and severity and acute disseminated encephalomyelitis (ADEM) was a close possibility because the events developed within 2 weeks of starting anti-rabies immunization (differential diagnoses). The patient was treated with acyclovir despite the suspicion of rabies encephalitis. The patient developed seizure and cardiac arrest and died on the same day. Brain and spinal magnetic resonance imaging (MRI) was requested but could not be performed as the patient died rapidly. On autopsy, biopsies of cerebral cortex, cerebellum, hippocampus and medulla were positive for rabies antigen on fluorescent antibody technique and diagnostic confirmation of rabies encephalitis was made. It was reported that the stray dog died few days before the child''s admission and was positive for rabies antigen on fluorescent antibody technique on brain biopsies. Rabies vaccine was given to the family and all health care workers with possible percutaneous or mucous exposure to the patient''s saliva before confirmation of the diagnosis. The author stated that in this patient with first symptoms were present on day 14 post exposure and this short incubation might be due to severe bite in the face. The author concluded the article stating that the child received appropriate post exposure prophylaxis, yet he died of rabies and the wound in the face, a zone richly innerved might explain the failure of prophylaxis. However, it was impossible to completely exclude errors in the management and a small transdermal puncture wound might have been missed and not irrigated, disinfected and injected with immunoglobulin. The bite wound was sutured on the same day which could also explain the failure of RPEP as this action could have enhanced the spread of the virus and rapid viral entry into the peripheral nerves where viruses were in an immune protected environment.


VAERS ID: 574716 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-02-09
Entered: 2015-02-09
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, 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: PHFR2015GB001219

Write-up: Case number PHFR2015GB001219 is an initial spontaneous report from a physician via medical affairs received on 03 Feb 2015 and a follow up report from the physician received on 05 Feb 2015. This report refers to a patient of an unknown age and gender. The patient was vaccinated with an influenza vaccine (manufacturer and batch number: not reported, conservatively coded as influenza vaccine INN) on an unknown date. On an unknown date, after vaccination the patient died due to influenza infection. The causality of the event was not reported. This case closed as lost to FU, as the physician refused to provide further information. Follow up report from the physician received on 05 Feb 2015: Changed the product coding from OPTAFLU to influenza vaccine INN.


VAERS ID: 574802 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:2015-01-27
Onset:0000-00-00
Submitted: 2015-02-04
Entered: 2015-02-10
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA012087

Write-up: Initial unsolicited report received from company representative on 27 January 2015. A 02-month-old patient (gender not reported), whose medical history and concomitant medications were not reported, had received an intramuscular 0.5 ml first dose of IMOVAX IPV (batch number- unknown, anatomical side of administration was not reported) on 27 Jan 2015. It was reported that patient sent to the hospital for rescue on 30 Jan 2015. Corrective treatment details and laboratory details were not reported. On 30 Jan 2015 patient was died. Documents held by sender: none.


VAERS ID: 574830 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:2015-01-30
Onset:0000-00-00
Submitted: 2015-02-09
Entered: 2015-02-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 13M01A / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Sudden infant death syndrome
SMQs:, Neonatal 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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015047063

Write-up: This is a spontaneous report from a contactable pediatrician. A 2-month-old male patient received PREVENAR 13 (Lot No. 13M01A, expiration date: 30Nov2016) at 0.5 ml single and ACT-HIB at 1 DF single, each of them given subcutaneously, on 30Jan2015, at his family doctor''s hospital. Medical history and concomitant medications were not reported. Around 24-48 hours after receiving the above mentioned vaccinations, the patient died due to sudden infant death syndrome on an unspecified date. The vaccinations were performed in accordance with the guideline on multiple vaccine injections. No symptom such as common cold was observed before or after the vaccinations. At the time of this report, judicial autopsy was being performed and investigation on cause of death was being conducted by police. Autopsy results were not yet available. The reporting pediatrician commented as follows: "although causality of the event to the vaccinations was not directly suspected, the event was reported just by way of precaution because of the short time between the vaccinations and the event onset".


VAERS ID: 574883 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2015-01-07
Onset:0000-00-00
Submitted: 2015-02-09
Entered: 2015-02-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death, Diet refusal, Eye swelling, Irritability, Meningitis, Pneumonia aspiration, Swelling, Walking disability
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015047385

Write-up: This is a spontaneous report received from a Pfizer colleague who came across an online newspaper article published 01Feb2015 via the medical information department. A 3 month old male patient of an unspecified ethnicity received PREVENAR 13 via an unspecified route of administration on 07Jan2015 for second routine vaccination. The patient medical history was not reported. The concomitant medications were not reported. The patient experienced aspiration pneumonia, his leg was lame, refused to breastfeed, his eyes were swollen, thinking that boy was just irritated by the injection, two days later she took baby to hospital when he would not stop crying, baby''s left side was swollen, meningitis, all on an unspecified date with outcome unknown. The patient died on 13Jan2015. It was not reported if an autopsy was performed. Published 01Feb2015. A mother alleges that her 3-month-old baby boy died from a vaccine he received in early January. The mother, said although the death certificate states that her baby boy died from aspiration pneumonia, she knew it was the vaccination that killed him. She took her baby for his second routine vaccination on 07Jan2015, where after his condition changed and he died a few days later. She showed the newspaper a disposable nappy, with a urine stain, which she claims was overpowered by dried powder that she believes was the medication injected into her baby. She describes her infant as a healthy baby, who looked older than his age and breastfed well. She said she has been informed of three causes of death. One nurse told her that the baby was born with bacteria on the brain and that this caused his death, while another said the baby died from meningitis, she said. She said that her baby''s health took a turn for the worse after his vaccination on 07Jan2015. His leg was lame and he was crying. He refused to breastfeed and his eyes were swollen. She said she did not worry too much at first, thinking that the boy was just irritated by the injection. Two days later she took the baby to hospital when he would not stop crying. She says the next day her baby''s left side was swollen. Despite all this, his weight or temperature did not change. She says she believes her baby died on 11Jan2015, even if the hospital only declared him dead two days later. All available information has been reported. No further information is expected.


VAERS ID: 574886 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2015-02-04
Onset:2015-02-04
   Days after vaccination:0
Submitted: 2015-02-11
   Days after onset:7
Entered: 2015-02-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1539 / 1 RA / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Hyperhidrosis, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA015021

Write-up: Initial unsolicited report received from the CDC via company representative on 05 February 2015. A 2-month-old male patient, whose medical history and concomitant medications were not reported, had received the first 0.5 ml intramuscular dose of ACT-HIB (Lot number J1539-1) in right arm, and 1 g of first dose of OPV, (manufacturer other and batch number was not reported) orally, both on 04 February 2015 at about 09:00 hours. On 04 February 2015, the parents found the patient was drowsy and sweating in the afternoon, and did not pay extra attention. Then they found the patient dead at night. Information about cause of death and autopsy was not reported. Complementary investigations and corrective treatments were not reported. List of documents held by sender: none.


VAERS ID: 575017 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:2015-01-30
Onset:0000-00-00
Submitted: 2015-02-12
Entered: 2015-02-18
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-02-03
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015SA013708

Write-up: Initial unsolicited report received from a pediatrician on 03 February 2015. A 02-month-old patient (gender: unknown), whose medical history and concomitant medication were not reported, had received subcutaneously 0.5 ml of first dose of ACTHIB manufacturer: SANOFI PASTEUR (batch number, dose of vaccine and site of vaccination were not reported), on 30-Jan-2015 and first dose of PREVENAR 13 manufacturer: OTHER, (batch number, dose of vaccine, route and site of vaccination were not reported), on 30-Jan-2015. On an unspecified date, patient died of sudden infant death syndrome. The death seemed to have occurred 24 to 48 hours after vaccination. When the patient was transported to the reporting hospital, he/she was in cardiac or respiratory arrest. Information on whether an autopsy was performed was not provided. Reporting pediatrician''s seriousness assessment: Serious (death). Reporting pediatrician''s causality assessment: Unknown. Reporting pediatrician''s comment: At this stage, the direct causal relationship with the event was unknown. The patient''s corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as patient''s death on 03-Feb-2015. Documents held by sender: none. Lab tests unknown. Cause(s) of death: Sudden Infant Death Syndrome.


VAERS ID: 575057 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-02-19
Entered: 2015-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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: GB2015GSK016061

Write-up: This case was reported by a non-health professional via interactive digital media and described the occurrence of influenza in a patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving influenza vaccine, the patient experienced influenza (serious criteria death). On an unknown date, the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the influenza to be related to influenza vaccine. Additional details were provided as follows: This case referred to a report where it was stated that an unspecified number of patients had died, possibly due to a lack of effect of the 2014-2015 season flu vaccine. This case was linked to case GB2015GSK016060 which was reported in the same article. No reporter''s details were provided to ensure FU.


VAERS ID: 575069 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2015-02-12
Onset:2015-02-13
   Days after vaccination:1
Submitted: 2015-02-18
   Days after onset:5
Entered: 2015-02-20
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR K0019 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cold sweat, Cyanosis, Mydriasis, Pallor, Pulse absent, Respiratory arrest, Sudden death, Sudden infant death syndrome, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), 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 (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-02-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2015SA018937

Write-up: Initial unsolicited report received from Center for Disease Control via company representative on 13 February 2015. A 02-month-old female patient, whose concomitant medication and medical history were not reported, had received intramuscularly first dose of, 0.5 ml of IMOVAX Polio (batch number: K0019-1) (site of vaccination not reported) on 12-Feb-2015 at 15:20 pm. Patient was normal in the 30 minutes observation after vaccination. On 13-Feb-2015 at 5:00 am, sudden infant death / no breathe; no response to light, mydriasis, no pulse, no heartbeat, pale face, cyanosis lips and wet skin was reported for which patient was taken to the hospital. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the patient was reported as sudden death on 13-Feb-2015. List of documents held by sender: none.


VAERS ID: 575160 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-06-01
Onset:2015-02-16
   Days after vaccination:625
Submitted: 2015-02-20
   Days after onset:4
Entered: 2015-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Myalgia, Pyrexia, Respiratory arrest
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-02-20
   Days after onset: 4
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: WAES1502COL009207

Write-up: This spontaneous report as received from the patient''s parent (also reported as a friend of the mother''s patient) via a social webpage refers to a 16 year old female patient. In June 2013, the patient was vaccinated with a dose of GARDASIL (dose and lot # not reported) intramuscularly. In March 2014, the patient experienced fever, muscular pain and other symptoms (not specified) that the physician could not control, no diagnosis was done. The consumer also reported that on 16-FEB-2015, the patient experienced respiratory arrest and died. The outcome of fever and muscular pain was reported as not recovered/not resolved. The relationship between the events and GARDASIL was not reported. Upon internal review respiratory arrest was considered to be medically signfiicant. Additional information has been requested.


VAERS ID: 575285 (history)  
Form: Version 1.0  
Age: 1.12  
Sex: Female  
Location: Foreign  
Vaccinated:2015-02-04
Onset:2015-02-06
   Days after vaccination:2
Submitted: 2015-02-20
   Days after onset:14
Entered: 2015-02-24
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC245A / 4 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J74077 / 4 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Malaise, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-02-09
   Days after onset: 3
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: 23-APR-2014, PREVENAR 13, No adverse effect, 1st dose; 11-JUN-2014, PREVENAR-13, No adverse effect, 2nd dose; 14-JUL-2014, PREVENAR-13, No adverse event, 3rd dose; 23-APR-2014, INFANRIX HEXA, No adverse effect, 1st dose; 11-JUN-2014, INFANRIX HEXA, No adverse effect, 2nd dose; 14-JUL-2014, INFANRIX HEXA, No adverse effect, 3rd dose
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015061569

Write-up: This is a spontaneous report received from the Health Authority. Regulatory Authority report number DE-PEI-PEI2015008196. A 13-month-old female patient of an unspecified ethnicity received on 04Feb2015 4th dose of PREVENAR 13 (batch/lot J74077), at 0.5 ml single on left thigh and 4th dose INFANRIX HEXA (batch/lot A21CC245A) at 1 DF single in right thigh, both intramuscular. The patient medical history and concomitant medications were not reported. The patient previously received both vaccines respectively on 23Apr2014 (1st dose), 11Jun2014 (2nd dose) and 14Jul2014 (3rd dose), all well tolerated. On 06Feb2015, the patient felt unwell and vomited several times. The patient did not receive treatment in the hospital or as outpatient and events malaise and vomiting recovered after 1 day. On 09Feb2015, the child died. According to the reporting physician, an autopsy will be performed. The case is serious as fatal and life threatening. Follow-up information has been requested. No follow-up attempts needed.


VAERS ID: 567071 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
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: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Mitral valve prolapse
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014SE68002

Write-up: A solicited report had been received from a health professional via Post-Licensure Surveillance of Influenza Vaccine from regulatory authority concerning a 25 year old, Male subject, who had been receiving FLUMIST quadrivalent, (intranasal). FLUMIST quadrivalent started on an unknown date. The patient experienced Idiopathic Mitral Prolapse. The patient died from the event of Idiopathic Mitral Prolapse on an unspecified date. An autopsy was performed. Assessment of the Serious criteria for the report was as follows: Death. Based on the information in this report, and awaiting the reporter''s assessment, the company physician considered the event idiopathic mitral prolapse to be unrelated to the FLUMIST.


VAERS ID: 567074 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-06
Entered: 2015-02-25
   Days after submission:142
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Laboratory test normal, Microscopy, Toxicologic test normal
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014SE77154

Write-up: A report has been received from a literature source, via regulatory authority, Vaccine Adverse Event Reporting System (VAERS) concerning a 19 years old female patient enrolled in an unsponsored non-interventional/post-marketing study. The patient died 10 days after receiving LAIV3, HPV and meningococcal conjugated vaccines. Despite and extensive postmortum examination including microscopic, neuropathological, toxicological, and chemical evaluation, the cause of death could not be ascertained. Assessment of seriousness criteria of the event was as follows: Death. Autopsy was performed. The company physician assessed the causality for the event, death with the suspect drug of FLUMIST as yes.


VAERS ID: 567078 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-06
Entered: 2015-02-25
   Days after submission:142
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Acute respiratory distress syndrome, Death, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (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), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant Drug (s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014SE77060

Write-up: A report has been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning a 41 year old, male patient. The patient''s medical history, concomitant disease and concomitant medications were not reported. On an unknown date, the patient received nasal FLUMIST (intranasal). After eleven days, the patient was hospitalized due to respiratory failure because of acute respiratory distress syndrome and possible community-acquired pneumonia. The outcome of the event of possible community-acquired pneumonia was unknown. The patient died from the event of respiratory faliure due to acute respiratory distress syndrome after twenty days of vaccine administration. The company physician assessed the event of respiratory failure to acute respiratory distress syndrome to be serious with death and hospitalization as serious criteria. The company physician captured the additional the event of possible community-acquired pneumonia and assessed it to be serious with hospitalization as serious criteria. Based on the information in this report, and awaiting the reporter''s assessment, the company physician considered the event of respiratory failure due to acute respiratory distress syndrome and possible community-acquired pneumonia to be not related to FLUMIST.


VAERS ID: 567080 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-08
Entered: 2015-02-25
   Days after submission:140
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Congestive 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: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions: Cardiac disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014SE77073

Write-up: A report had been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning a 21 year old, male subject, who had been receiving FLUMIST (intranasal). The patient''s medical history included heart disease. FLUMIST (Intranasal) started on an unknown date. It was reported that an autopsy determined the cause of death was dilated cardiomyopathy. The patient died from the event of dilated cardiomyopathy on an unspecified date. An autopsy was performed. The reporter''s description of the event(s) was as follow. A 21-year-old male with a family history of heart disease died 3 days after receiving LAIV3. An autopsy determined the cause of death was dilated cardiomyopathy. Assessment of the serious criteria for the report was as follows: Death. Based on the information in this report and awaiting the reporter''s assessment, the company physician considered the causality between the event dilated cardiomyopathy with the suspect drug of FLUMIST to be unrelated.


VAERS ID: 575279 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-02-25
Entered: 2015-02-25
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: 2015049051

Write-up: This medically confirmed health authority report (initial receipt 17-Feb-2015) concerns an unknown age and gender patient. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date following the vaccination, the patient died due to influenza infection. The causality of the event was not reported. The outcome was reported as fatal. Reporter''s comments: The regulatory authority assessed the case as serious (fatal). This case was closed as lost to follow-up as the physician refused to provide further information.


VAERS ID: 575349 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-11
Onset:2015-02-13
   Days after vaccination:94
Submitted: 2015-02-25
   Days after onset:12
Entered: 2015-02-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 148201A / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Multi-organ failure, Vaccination failure
SMQs:, Lack of efficacy/effect (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), 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: 2015-02-17
   Days after onset: 4
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: Endocarditis; Myocarditis; Cardiac failure chronic; Chronic obstructive pulmonary disease; Sleep apnoea syndrome; Obesity; Cardiac assistance device user
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015DE022198

Write-up: Case number PHHY2015DE022198 is a combined initial and follow up spontaneous report from a physician via Novartis Medical Information Center (MIC: 1-411909385) received on 24 Feb 2015. This report refers to a 47-year-old male patient. His current conditions included an endocarditis and myocarditis due to which the patient suffered since several year from chronic heart failure. He had a pacemaker, chronic obstructive pulmonary disease (COPD grade III to IV), sleeping apnea and was obese. On 11 Nov 2014, the patient was vaccinated with BEGRIPAL (batch number: 148201A). On 13 Feb 2015, the patient suffered from multi organ failure and influenza. The physician reported a vaccination failure. The patient was hospitalized due to the events. The patient died on 17 Feb 2015 at 01:30 due to multi organ failure and influenza. No autopsy scheduled. At the time of reporting, no additional information was available and medical reports as well as testing results for detection of influenza were requested. The causality of the events was not reported.


VAERS ID: 575461 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-03-04
Entered: 2015-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Contraindication to vaccination, Death, Measles post vaccine, Viral infection
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Immunodeficiency, STAT2-deficiency was associated with profound failure of type I interferon signaling, which is thought to be responsible for the observed defect in innate antiviral immunity.
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1503BEL000228

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer # E2015-02048) on 27-FEB-2015. Serious case retrieved from the literature on 24-Feb-2015. This case was also a case of disseminated vaccine-strain measles. Case of vaccination error: contraindication to vaccination (immunodeficiency). STAT2-deficiency has been proposed as the cause of unusually severe viral illness in infancy in two siblings who developed disseminated vaccine-strain measles following routine immunization and of whom one sibling died from an unknown viral infection. STAT2-deficiency was associated with profound failure of type I interferon signaling, which is thought to be responsible for the observed defect in innate antiviral immunity. Method: whole-exome sequencing was performed on a 9-year-old girl who presented with frequent and severe viral infections from birth including complicated measles following immunization with MMR vaccine at the age of 12 months. Results: a compound heterozygous p.G522R and p.R506X mutation in STAT2 leading to STAT2-deficiency in the index patient was identified. Beside vaccine-strain measles, she experienced frequent viral infections of varying severity including enteroviral meningitis, recurrent varicella zoster infection, persistent warts and mollusca contagiosa. She also showed persistently high Epstein-Barr virus copy numbers in blood and cerebrospinal fluid. The mutations were confirmed by Sanger sequencing in the index patient and in a male sibling who presented in a similar way. He had a relatively infection-free window from the age of 4 years on but then succumbed to an infection with an unidentified agent at the age of 7 years. Conclusion: this finding confirms STAT2-deficiency as a cause of a defect in innate antiviral immunity. It demonstrates that, although the frequency of viral infections decreases with increasing age, patients may still be at risk for overwhelming viral illness at a later age. This case concerns the male patient who developed disseminated vaccine-strain measles following routine immunization after the vaccination with the MMR vaccine (no trade name, batch number reported) administered on an unspecified date. The patient had a relatively infection-free window from the age of 4 years on but then succumbed to an infection with an unidentified agent at the age of 7 years. Cause of death: unknown viral infection. This case is linked to the case E2015-02042 (patient''s sister).


VAERS ID: 575711 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2015-02-01
Submitted: 2015-03-04
   Days after onset:31
Entered: 2015-03-10
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Loss of consciousness, Pneumococcal sepsis
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015076532

Write-up: This is a spontaneous report from a contactable physician via a Pfizer representative. A currently 7-year-old female patient of unspecified ethnicity received PREVENAR single dose, via an unspecified route of administration on an unspecified date reported as "in the past". The patient medical history was not reported. The patient''s concomitant medications were not reported. On an unspecified date in Feb2015, the patient''s parents brought her to the doctor''s office unconscious and she could not be woken up. The physician admitted the patient into the hospital with suspected pneumococcal sepsis. An antibiotic therapy was immediately initiated at the hospital. It was reported that the disease course was so foudroyant, that the child died in the hospital on the same evening. It was reported that the definition of the serotypes were pending. It was unknown if an autopsy was performed.


VAERS ID: 575852 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2014-10-04
Onset:2014-10-04
   Days after vaccination:0
Submitted: 2015-03-13
   Days after onset:160
Entered: 2015-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 28949411A / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthralgia, Atrial fibrillation, Cardiac failure acute, Death, Rash generalised, Vasculitic rash
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Vasculitis (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-01-20
   Days after onset: 108
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: Amlodipine; aspirin; atorvastatin; nicorandil; ramipril
Current Illness:
Preexisting Conditions: Ischaemic heart disease; Polymyalgia rheumatica
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015049393

Write-up: This medically confirmed health authority report (initial receipt 27-Feb-2015) concerns a male patient who had concomitant conditions of ischaemic heart disease and polymyalgia rheumatica (started in 1997). Concomitant medications included amlodipine, aspirin, atorvastatin, nicorandil and ramipril. Amlodipine and ramipril was taken for hypertension and other concomitant medications were taken for ischaemic heart disease. On 04-Oct-2014, the patient received intramuscular AFLURIA (batch number 28949411A) 0.5 mL. On 04-Oct-2014, a few hours following the routine vaccination, the patient developed a generalised rash and joint pains a few hours later. He had a vasculitic type rash. Patient then developed atrial fibrillation and died of acute heart failure on 20-Jan-2015. The outcome was reported as fatal (due to acute heart failure) and not recovered for atrial fibrillation, generalised rash, joint pain and vasculitic rash. Reporter''s comments: The regulatory authority assessed the case as serious (led to hospitalisation and fatal outcome).


VAERS ID: 575866 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-03-13
Entered: 2015-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Hyperventilation
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1503JPN006370

Write-up: Initial information has been received from a pharmacist concerning an elderly female patient who on an unspecified date was vaccinated subcutaneously with PNEUMOVAX NP injection drug (Lot number, vaccination date, dose and indication were not reported). There was no concomitant medication reported. On an unspecified date, the patient died from hyperpnoea after she was inoculated with the PNEUMOVAX NP. It was not reported whether an autopsy was performed or not. Reporter''s comment: The details were unknown because the patient was not in the hospital ward. It was unknown whether it was anaphylaxis or not. And it was also unknown whether it was a routine vaccination or a voluntary one. The reporting pharmacist considered that the hyperpnoea was serious due to death. The reporting pharmacist did not assess the relationship of hyperpnoea to PNEUMOVAX NP. Additional information has been requested.


VAERS ID: 575910 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-18
Onset:2014-11-26
   Days after vaccination:8
Submitted: 2015-03-12
   Days after onset:105
Entered: 2015-03-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Agitation, Altered state of consciousness, Asthenia, Blood test, Brain death, Brain oedema, CSF test normal, Central nervous system lesion, Coma scale abnormal, Computerised tomogram head abnormal, Crying, Death, Depressed level of consciousness, Diarrhoea haemorrhagic, Diet refusal, Dystonia, Endotracheal intubation, Fatigue, Gastroenteritis, Headache, Hypertension, Intensive care, Intermittent claudication, Intracranial pressure increased, Irritability, Leukaemia, Lumbar puncture normal, Mechanical ventilation, Mucous stools, Muscle contracture, Pain in extremity, Paraesthesia, Paresis, Personality change, Posture abnormal, Pupillary light reflex tests abnormal, Pyramidal tract syndrome, Pyrexia, Seizure, Somnolence, Tachycardia, Unresponsive to stimuli, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (narrow), Hypertension (narrow), Demyelination (narrow), Retinal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-06
   Days after onset: 10
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: No other medications
Current Illness: Thrombocytopenia; Leukaemia; Dysmorphism; Facial asymmetry; Speech disorder developmental; Developmental delay
Preexisting Conditions: Benzodiazepines; Mechanical ventilation; Finger deformity; Endotracheal intubation
Allergies:
Diagnostic Lab Data: Blood test, Results not provided; 11/26/2014, Body temperature, greater than or equal to 38 degrees C, High; 11/27/2014, Body temperature, greater than or equal to 38 degrees C, High; CSF test, Normal, The liquor was without suggestive changes of infection; Coma scale, 8, Significant; Computerised tomogram head, Cerebral death, Significant, CT scan was performed to confirm patient status (cerebral death); 11/27/2014, Computerised tomogram head, Normal; 12/03/2014, Computerised tomogram head, Abnormal, Significant, Changes suggestive of ADEM (encephalomyelitis of immunological cause); 12/05/2014, Computerised tomogram head, Abnormal, Significant, CT showed worsening of initial lesions with diffuse cerebral edema on 05 Dec 2014 and signs of wedge; 12/03/2014, Lumbar puncture, Normal, cytochemical examination was without significant variations; bacteriology and virology examinations and search of oligoclonal bands were undergoing. The liquor was without suggestive changes of infection and the results were normal
CDC Split Type: PHHY2014PT165618

Write-up: Case number PHHY2014PT165618 is an initial spontaneous report from a physician via health authority (HA reference number: PT-INFARMED-N201412-297) received on 17 Dec 2014 with a combined follow up information received physician and quality assurance department (QA reference number: 343913) on 19 Dec 2014 with a follow up report received from the physician on 23 Dec 2014 and a follow up information received from physician via health authority (HA reference number: PT-INFARMED-N201412-599) on 13 Feb 2015. This report refers to a 5 years old female patient. Her vaccination history included a dose of hepatitis A vaccine (manufacturer and batch number: not reported) one year before and first dose of BEXSERO (batch number: not reported) on 24 Aug 2014 and there was no adverse reactions after first dose. It was reported that the patient had no relevant clinical history until the date of the adverse event. She had no history of recent traveling. There was no history of other contacts infected with similar symptoms. In the postpartum, she had neonatal pathology thrombocytopenia following which she was admitted in oncology institute and was discharged with diagnosis of latent transient leukemia. The patient was followed for more than a year. Her current conditions included minor dysmorphia, deficiency in the fingers, facial asymmetry and retardation in development and speech and these were being investigated at genetic institute (no other information available). Her concomitant medications were not reported. Antecedents of adverse reactions to other medicines were unknown. She was vaccinated with second dose of BEXSERO (batch number: unknown) intramuscularly in 18 Nov 2014. On 26 Nov 2014, she had gastroenteritis of unknown etiology (diarrhea for duration of three days) characterized by blood and mucus and vomiting. She had a cerebral computed tomography (CT) scan done on 27 Nov 2014 which was normal. On 27 Nov 2014, she had fever with a body temperature greater than or equal to 38 degree C and strong headaches. She received a fluid therapy. On 30 Nov 2014, fever, bloody diarrhoea and headache stopped. The fever resolved when gastroenteritis was resolved. It was reported that she was very prostrate and sleepy. She was discharged since the symptoms improved. During the weekend, she experienced lack of strength, prostration and irritation and the events got worsened. She only wanted to sleep and there was a changed in level of conscience. This state worsened on 30 Nov 2014. On 02 Dec 2014, three weeks after second dose of vaccination; she went to the emergency department of the residential rea at 3 am in the morning with marked agitation and irritability. She was already apyretic and had gastrointestinal complaints. She had prostration, partial food refusal, paraesthesia and pain in the right lower limb with claudication. She was discharged after observation and analytical study performed referred her as normal. At home she was slightly better, but during the night appeared irritable and was shouting and crying. She had dystonic posture with cephalic deviation towards right, paresis of left upper limb and 4 episodes of vomiting. On 03 Dec 2014 morning, she was reactive slightly with conjugated deviation of the sight to the right and was greatly irritable while handling. She was transported to the hospital emergency room. On 03 Dec 2014, she was almost not able to respond. A CT scan performed showed changes suggestive of acute disseminated encephalomyelitis which was further described as new hypodense cortical-subcortical focus in the left internal (medial) parietal region, badly delimited with mass effect which could be of ischemic or infectious nature. On objective examination, she presented variations of the conscious state (agitation periods and irritability which were calmed down with mother''s contact) with conjugated deviation of the eyes to the right. Her pupils were isochoric and photoreactive. She had left upper limb paresis with pyramidal signal of the 4 members (left$gright), arterial hypertension and tachycardia. The physician reported that event was hyperacute. There was no fever. No nuchal rigidity was observed by the physician. She had depressed or altered level of consciousness, personality change, inconsistent or absent response to external stimuli, visual field defect, presence of primitive reflexes and motor weakness. She was greatly neurologically affected and whole body contracted. Her Glasgow coma scale was almost in score 8. During hospitalization, diagnostic tests were performed with samples of cerebrospinal fluid (CSF). Lumbar puncture was performed and cytochemical examination was without significant variations; bacteriology and virology examinations and search of oligoclonal bands were undergoing. The liquor was without suggestive changes of infection and the results were normal. No magnetic resonance imaging (MRI) was performed. She was detected with immunological complications. She had convulsive seizure which ceded with intravenous diazepam. Methylprednisolone was started intravenously at a dose of 30 mg/kg and she was transferred to the intensive care unit with the diagnosis of probable acute disseminated encephalomyelitis (ADEM). After this diagnosis, she was transferred to another hospital for neurological observation. She was then admitted in the intensive pediatric unit care during the night (on 04 Dec 2014 at 2:30 am). On admission, she presented the same neurological state (ECG 9) with arterial hypertension and tachycardia. The neurological state worsened and the outcome was not favorable. She was treated with benzodiazepines for the event. During the night, the events became worse and she required ventilation. She was intubated and measures of intracranial hypertension control were implemented without success. Repeated cranioencephalic CT showed worsening of initial lesions with diffuse cerebral edema on 05 Dec 2014 and signs of wedge. All sedoanalgesic medications introduced were suspended. Cerebral death was declared by the physician. The patient was only declared dead nearly 28 hours after, on 06 Dec 2014 at 11 am. After cerebral death, a CT scan was performed to confirm the patient''s status (cerebral death). The child was hospitalized during 4 days until being declared the brain death. The physician stated that blood tests were performed and the results of the blood tests were not reported and there might be stored specimens for additional testing. The physician did not have any additional information from genetic institute and no reports were available. According to the physician, stool tests were not performed and no information about gastroenteritis etiology was available. The final diagnosis was acute disseminated encephalomyelitis (ADEM). An autopsy was not performed as the parents refused it. The health authority assessed the event serious. The health authority reported the causality of the event as suspected to be related to the use of BEXSERO. The physician who analyzed the patient stated that vaccination or viral infection were two possible causes that led to the occurrence of the event. As per physician who evaluated the patient in the intensive pediatric care, she had a problematic immunity system and the cause of acute disseminated encephalomyelitis could be associated to gastroenteritis or vaccination as both conditions influence immunity system. The physician was not able to establish an association and had doubts about it. Based on the performed review on BEXSERO batches 131401A, 130301, 143301 and 144901, there was no evidence of any objections which occurred during the manufacturing process of finished product, including adjuvant and components used, that could compromise the quality of the product or that might be potentially related to the reported events. The quality assurance department confirmed that the involved batches were compliant with internal procedures and with current good manufacturing practices (cGMP) requirements. Combined follow up information received physician and quality assurance department (QA reference number: 343913) on 19 Dec 2014: Updated vaccination history, medical history, suspect vaccine date, events (encephalitis recoded as ADEM and added all other events) and physician comment and batch investigation summary updated. Follow up report was received from the physician on 23 Dec 2014: Updated lab investigations and reporter''s comments. Follow up information received from physician via health on 13 Feb 2015: Updated events (altered state of consciousness, cerebral oedema, convulsion, dystonia, eating disorder, hypertension, pain in extremity, pupillary light reflex tests abnormal, tachycardia, crying, paraesthesia, diarrhea, diarrhea hemorrhagic, pyramidal tract syndrome and hyporesponsive to stimuli), laboratory tests, procedure, clinical course of the event and treatment.


VAERS ID: 576034 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2015-02-26
Onset:2015-03-03
   Days after vaccination:5
Submitted: 2015-03-17
   Days after onset:13
Entered: 2015-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 131301 / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Blood bicarbonate decreased, Blood pH decreased, Bradycardia, C-reactive protein increased, Carbon dioxide increased, Death, Dehydration, Electrocardiogram abnormal, Endotracheal intubation, Hyperpyrexia, Hypothermia, Laboratory test abnormal, Leukopenia, Livedo reticularis, Mechanical ventilation, Neutropenia, Neutrophil count decreased, Pallor, Peripheral venous disease, Platelet count decreased, Pyrexia, Septic shock, Sinus tachycardia, Tachyarrhythmia, Thrombocytopenia, Waterhouse-Friderichsen syndrome, X-ray abnormal
SMQs:, Agranulocytosis (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Accidents and injuries (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 03/03/2015, Endotracheal intubation; 03/03/2015, Mechanical ventilation
Allergies:
Diagnostic Lab Data: 03/03/2015, Blood bicarbonate, 11.8, Significant; 03/03/2015, Blood pH, 6.89, Low; 03/03/2015, C-reactive protein, 5.88 mg, High; 03/03/2015, Carbon dioxide, 62, Significant; 03/03/2015, Electrocardiogram, Abnormal, Significant, evidence of sinus tachycardia with tendency to bradycardia crisis; 03/03/2015, Electrocardiogram, Abnormal, Significant, idioventricular rhythm with enlarged QRS at heart rate of 65 to 70/minutes; 03/03/2015, Heart rate, 190/min, High; 03/03/2015, Heart rate, 195/min, High; Laboratory test, Abnormal, Significant, infection has been characterized as a MenB serogroup; 03/03/2015, Neutrophil count, 700/mmc, Low; 03/03/2015, Platelet count, 59.0/mmc, Low; 03/03/2015, X-ray, Abnormal, Significant, reduction in the lung diaphany at the III medium superior of the right lung without representation of the intestinal meteorism with distension of one intestinal ansa projectively in the mesogastrium
CDC Split Type: PHHY2015IT026937

Write-up: Case number PHHY2015IT026937, is a combined initial spontaneous report from a physician via Novartis employee and a healthcare professional via health authority (HA, reference number: 297337) received on 05 Mar 2015, with a follow up report received from the quality assurance department (QA, reference number: 355706) on 06 Mar 2015, with a combined follow up report received from a biologist via Novartis employee and a lay press newspaper article (journalist) on 05 Mar 2015 and from a lay press newspaper article on 06 Mar 2015, with a combined follow up report received from a lay press article and the QA department (reference number: 355706) on 09 Mar 2015 and 10 Mar 2015 respectively, with a follow up report received from the HA on 13 Mar 2015. This report refers to an 11 weeks old male neonate. Medical history and concomitant medications were not reported. He was vaccinated with first dose of BEXSERO (batch number: 131301, expiry date: 31 Mar 2015) on 26 Feb 2015. Further to the vaccination, the patient showed unspecified increased polymerase chain reaction (PCR) value, neutropenia, thrombocytopenia (septic shock). On 03 Mar 2015, the pediatrician visited the patient''s home and suggested hospitalization due to severity of conditions including fever. On 03 Mar 2015 at hour 12:48, he was admitted to a pediatric ward due to hyperpyrexia for 6 hours. At the pediatric ward it was noted that the patient was in poor clinical conditions, sufferance behavior, pale and septic color, dehydrated, tachycardic pulse (heart rate (FC) was 190/minutes). At the same department venous access was found. He was given Ceftriaxone (300 mg) and Methylprednisolone (10 mg) endovenously. The ceftriaxone showed no response. The condition worsened. The patient was transferred another emergency department from the pediatric ward of the local town with the assistance of the pediatrist and of an anesthesiologist at 13:50 hours. During hospital admission, there was a marked increase in C-reactive protein level with a value of 5.88 mg. He was in critical conditions. The patient had paleness of the skin, marble-like appearance, hypostasis phenomena, peripheral pulses filiform, hypothermia, tachyarrhythmic cardiac sounds, sensorium obnubilation with tendency to the soporous status. Hematobiochemical blood drawn has been performed and hemogasanalysis through venous access at the femoral vein showed very severe mixed acidosis. His blood pH was 6.89, pCO2 was 62, EB was 20.8 and bicarbonate was 11.8. Due to this observation, a tracheal intubation was performed and mechanical ventilation was started. An electrocardiogram showed evidence of sinus tachycardia at heart rate of 195/minutes with tendency to bradycardia crisis. For this reason, endotracheal Adrenaline was given along with Hydrocortisone at anti-shock dosage (250 mg) and sodium bicarbonate (20 cc) was given endovenously at 14:10 hour. At hour 14:20, in order to be able to find a venous access more congruous and taking into account the extreme criticality of the situation, an intra-osseous puncture under emergency was performed. A physiological solution (unspecified) was infused at anti-shock velocity (40 ml/hour). His arterial pressure was not detectable (Dinamap method), unique vital parameter was detectable in the ECG. He was given bicarbonate infusion at a dose of 10 cc at 14:25 hours. On the same day at 14:40 hours, 20 mg of Ceftriaxone was administered endovenously. At 14:46 hour, a chest-abdominal X-ray was requested which showed reduction in the lung diaphany at the III medium superior of the right lung without representation of the intestinal meteorism with distension of one intestinal ansa projectively in the mesogastrium. At 14:50 hour, a peripheral blood smear test was performed which showed evidences of leucopenia with severe neutropenia (700/mmc) and thrombocytopenia (59.000/mmc). On the basis of this result (highly evocative for a septic picture) a Gentamycin was administered endovenously at a dose of 12.5 mg at 15.00 hours. His condition was extremely critical with succeeding bradycardia at 15:10 hours. He was given prolonged external cardiac massage and further bicarbonate and adrenaline infusions were performed. An ECG recording shows idioventricular rhythm with enlarged QRS at heart rate (FC) of 65 to 70/minutes. At 15:30 hour, there was absence of response to any stimulation, fixed mydriasis and extreme bradycardia resistant to the resuscitation maneuvers. At 15:50 hours, there was no cardiac electrical activity. Death was certified due to septic shock. Autoptic evaluation was requested. On 04 Mar 2015, a blood sample of the pediatric patient was sent to an institute where the search for bacterial DNA with CRP real time method gave positive outcome for Neisseria meningitidis B serum group. Biologist highlighted that a single lower dosage of vaccination, was not considered sufficient to confer protection. In a lay press it was reported that a syndrome of Waterhouse-Friderichsen (a form of complication to meningitis) killed the infant. Initially BEXSERO was considered as a possible cause of death, but the results of the analysis did not confirm this hypothesis. It was possible that, when he was vaccinated and seemed to be healthy, the infant was already incubating the disease. The physicians confirmed that there would be no correlation between the events and the vaccine administered one week prior. A tissue sample was collected from the body of the baby which would be subjected to histological examination. Based on analysis performed on the first blood samples, it was reported that the baby had been hit by an event "fulminant infectious." On 05 Mar 2015, autoptic examination was performed but definitive results were not available. The causality of the event septic shock was reported as suspected by health authority and for the event syndrome of Waterhouse-Friderichsen was reported as non-suspected by the physicians. Based on the performed review on BEXSERO batch 131301, there is no evidence of any objections which occurred during the manufacturing process of finished product, including adjuvant and components used, that could compromise the quality of the product or that may be potentially related to the reported events. QA confirmed that the involved batch is compliant with internal procedures and with cGMP requirements. Non-significant follow up report received from the quality assurance department (QA, reference number: 355706) on 06 Mar 2015: Updated QA reference number. Combined follow up report from a biologist via Novartis employee and from a lay press newspaper article (journalist) received on 05 Mar 2015 and from a lay press newspaper article received on 06 Mar 2015: Added event (syndrome of Waterhouse-Friderichsen), analysis information and causality of the event. Follow up report received from the QA department (reference number: 355706) on 10 Mar 2015: Updated BEXSERO vaccine batch review report. A combined follow up report received from a lay press article and the QA department on 09 Mar 2015 and 10 Mar 2015 respectively: Updated reporter''s statement and batch review report. Follow up report received from the HA on 13 Mar 2015: Updated details on hospitalization, condition during transfer to a second hospital, event details, laboratory tests, procedures and treatments received, cause of death and other clinically relevant information in the narrative.


VAERS ID: 576244 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-03-15
Onset:2015-03-15
   Days after vaccination:0
Submitted: 2015-03-20
   Days after onset:5
Entered: 2015-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1503ISR008679

Write-up: This spontaneous report as received from a consumer (also reported as the patient''s daughter) concerns a 64 year old female patient. The concurrent conditions and medical history of the patient were not reported. On 15-MAR-2015 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On 15-MAR-2015 (in the evening) the patient died perhaps due to a heart attack (death and medically significant). It was still not clear what the cause of death was and there was no background of any cardiovascular disease. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the event was reported as fatal. The relatedness of the event to the therapy with ZOSTAVAX was unknown. Upon internal review, heart attack (myocardial infarction) was determined to be medically significant. Additional information has been requested.


VAERS ID: 576272 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2015-01-19
Onset:2015-01-19
   Days after vaccination:0
Submitted: 2015-03-17
   Days after onset:56
Entered: 2015-03-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bronchitis, Death, Rhinitis
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: 2015090112

Write-up: This is a spontaneous report from a contactable consumer (patient grandmother) received from the Health Authority. Regulatory authority report number DE-PEI-PEI2015013638. A female patient of an unspecified age and ethnicity received the first dose of (0.5 ml single) of PREVENAR 13, the first dose (1 dosage form single) of HEXYON and a third unknown vaccine, all for prophylaxis on 19Jan2015. The patient medical history and concomitant medications were not reported. On 19Jan2015, the patient developed bronchitis and rhinitis without fever, with an unknown outcome. Fourteen days later, on an unspecified date in Feb2015, the child died on a walk for death infant sudden. It was not reported whether an autopsy was performed.


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