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VAERS ID: 734246 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Yellow fever vaccine-associated viscerotropic disease
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2018SA012108

Write-up: Initial unsolicited report received from a consumer (unspecified relationship with the patient) via social media on 12-Jan-2018. This case is linked with: 2018SA012101, 2018SA012100, 2018SA012104, 2018SA012105, 2018SA012103, 2018SA012107, 2018SA009914. (same reporter). This case involves four years old patient (gender not reported) who was vaccinated with a dose of YELLOW FEVER VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history was not reported. No information regarding premedication, concomitant medication or previous therapy was provided. On an unspecified date, post vaccination, the patient died due to a reaction to the vaccine called acute viscerotropic disease considered rare. It was reported that the patient was not ill until receiving the vaccine and on an unknown date the patient was hospitalized. It was also informed that the virus penetrated the liver tissue and that the science did not explain why instead of protecting the patient, the vaccine with the weakened virus, infected the patient. Laboratory investigations and corrective treatment was not reported. It was not reported whether autopsy was performed. The case was also considered as serious as the patient died due to the event. List of documents held by sender: none. Sender''s Comments: This is a poorly documented medically unconfirmed case, reported from social media and that occurred on unspecified date. Reportedly, a 04 year old patient (gender nor reported) died from YEL-AVD on unspecified time after vaccination with Yellow fever vaccine (manufacturer unknown). It was reported that vaccine virus penetrated liver tissue. Patient''s medical history, immune status at the time of vaccination, time to onset, symptoms and their evolution, time to death, detailed results of investigations (etiological, confirmatory for the diagnosis, autopsy) are needed to further assess this case. Reported Cause(s) of Death: acute viscerotropic disease.


VAERS ID: 734356 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-02-04
Onset:2017-02-10
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2018-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Death, Jaundice, Leptospirosis, Malaise, Pyrexia, Vaccination complication, Varicella
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-16
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chickenpox
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2018SA012104

Write-up: Initial unsolicited report received from consumer (unspecified relationship with the patient) which forwarded a report from a Social Media on 12-Jan-2018. This case is linked with 2018SA012100 (S-408 A), 2018SA012103 (S-408 C), 2018SA012101 (S-408 B), 2018SA012105 (S-408 E), 2018SA012107 (S-408 F), 2018SA012108 (S-408 G) and 2018SA009914 (Same reporter). This case involves 39 years old male patient who was who was vaccinated with dose of YELLOW FEVER VACCINE (batch number, expiry date, route and site of administration were not reported) on 04-Feb-2017. On 31-Jan-2017, 14 days after receiving the vaccine the patient experienced chickenpox. Concomitant medication was not reported. On 10-Feb-2017 six days post vaccination patient had experienced malaise, with symptoms of high fever and jaundice and looked for medical assistance. On 16 Feb 2017, 12 days post vaccination patient was died due to an unspecified reaction. On an unspecified date post vaccination patient had leptospirosis. As Regional Health Coordination suspected the cause of death was leptospirosis, as the patient worked on a rural property where there were rats. However, the blood samples of the patient, collected three days before his death (estimated by 13-Feb-2017), and of his organs that were collected after the patient died, let no doubt, the patient died due to a vaccine reaction (Diagnosis: Yellow fever vaccine-associated viscerotropic disease). Other lab test and corrective treatment were not reported. The State Health Secretary mentioned that it was believed that the patient was experiencing low immunity and, for this reason, had problems with the vaccine. It was not reported whether autopsy was performed. List of documents held by sender: none. Sender''s Comments: This is a poorly documented medically unconfirmed case, reported from social media and that occurred in January 2017. Reportedly, 39-y.o. male patient developed high fever with jaundice 6 days after vaccination with YF vaccine (manufacturer unknown) and died 12 days after vaccination. Blood samples collected three days before his death, and of organs samples collected post-mortem, confirmed role of the vaccine (detailed results not reported). It was believed that the patient was experiencing low immunity. Patient''s past medical history, health status at the time of vaccination, as well as detailed results of investigations are needed for further assessment of the case. Reported Cause(s) of Death: definite YEL-AVD; Unspecified reaction; high fever; Jaundice; Suspicion of leptospirosis; malaise.


VAERS ID: 734559 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-18
Entered: 2018-01-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA2018GSK008522

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a 92-year-old patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to SHINGRIX. The additional details were provided as follows: The patient''s age at vaccination could be 91 or 92 years. The pharmacist was inquiring about SHINGRIX and said it was mentioned at a Continuing Education event that a 92 year old had died after getting 1 dose of SHINGRIX. It was unknown if an autopsy was performed or not. No further details were provided. No consent to follow up was reported.


VAERS ID: 734579 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-07-16
Onset:2016-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Drug administered to patient of inappropriate age, Head discomfort, Prescription drug used without a prescription, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AR0095075131801ARG006445

Write-up: This spontaneous report was received from a consumer (patient''s mother) regarding her 33 year old male son. Information on pertinent medical history, concomitant medications and concurrent conditions were not reported. It was reported that the patient went to the pharmacy to get flu vaccine, but as they had no stock, the pharmacist recommended PNEUMOVAX 23 warning him that he could experience a little fever and that it was normal. On approximately 16-JUL-2016 (also reported as a year and a half ago), the patient was vaccinated with PNEUMOVAX 23 injection (strength, dose, frequency, route of administration, lot# and expiry date were not reported) for prophylaxis in the same pharmacy without a medical prescription. On an unknown date (also reported as after a while), the patient began to experience fever. The patient was treated with NOVALGINA. On an unknown date, the patient died (also reported as "his head exploded"). It was unknown if an autopsy was performed. Outcome of the events, fever and "his head exploded" was reported as fatal. The cause of death was reported as fever and "his head exploded". Causality of the events, fever and "his head exploded" was unknown. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the investigational therapy and the remaining reported events of pyrexia and head injury cannot be established. Missing important information includes medical history, comorbid conditions, concomitant medications, clinical course and onset dates of the events. Company Comment- No changes to the investigational product safety information are warranted at this time. Merck and Co., Inc., known as MSD outside of certain countries, continues to monitor the safety profile of the investigational product. Reported Cause(s) of Death: the patient began to experience fever which was treated with NOVALGINA, but died "his head exploded".


VAERS ID: 734759 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2017-12-24
Submitted: 0000-00-00
Entered: 2018-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R91267 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Drug ineffective, Pneumococcal infection
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2018029395

Write-up: This is a spontaneous report from a physician downloaded from the Regulatory Authority-WEB [regulatory authority number: DE-PEI-PEI2018000003]. A 13-month-old male patient of an unspecified ethnicity received the 2nd dose of PREVENAR 13 (Lot # R91267) vaccination for prophylactic immunisation. The patient medical history and concomitant medications were not reported. The patient previously took PREVENAR 13 for immunisation. On 24Dec2017, the patient experienced pneumococci that required hospitalization. The patient died on an unspecified date. Reported cause of death was pneumococcal infection. It was unknown if an autopsy was performed. The agency assessed the event as unclassifiable. No follow-up attempts needed, follow-up automatically provided by regulatory authority. Reported Cause(s) of Death: Drug ineffective; Pneumococcal infection.


VAERS ID: 734789 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-24
Entered: 2018-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK012189

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Flu Seasonal QIV Dresden. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving influenza vaccine quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to influenza vaccine quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The consumer posted on social media about 8 flu deaths of which, 7 had the flu shot and all 8 took THERAFLU. The consumer asked what''s your take on who is to blame? It was unknown if an autopsy was performed or not. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. This case is one of the 7 cases, reported by the same reporter for same event.


VAERS ID: 734799 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-24
Entered: 2018-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK012202

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. The consumer posted on the internet about 8 flu deaths of which, 7 had the flu shot and all 8 took THERAFLU. The consumer asked what''s your take on who is to blame? It was unknown if an autopsy was performed or not. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. This case is one of the 7 cases, reported by the same reporter for same event.


VAERS ID: 734811 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-24
Entered: 2018-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THERAFLU
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2018GSK012207

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. The consumer posted on the internet about 8 flu deaths of which, 7 had the flu shot and all 8 took THERAFLU. The consumer asked what''s your take on who is to blame? It was unknown if an autopsy was performed or not. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. This case is one of the 7 cases, reported by the same reporter for same event.


VAERS ID: 734968 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2017-12-26
Submitted: 2018-01-23
   Days after onset:28
Entered: 2018-01-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-26
   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: Nasopharyngitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: NO2018008816

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of sudden infant death in a 1-month-old male patient who received ROTARIX. The patient''s past medical history included common cold. In December 2017, the patient received the 1st dose of ROTARIX (oral). On 26th December 2017, 6 days after receiving ROTARIX, the patient experienced sudden infant death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the sudden infant death was fatal. The patient died on 26th December 2017. The reported cause of death was sudden infant death. An autopsy was performed. It was unknown if the reporter considered the sudden infant death to be related to ROTARIX. Additional information: Age at vaccination was not reported. Initial information was received from a physician via regulatory authority on 18th January 2018: Sudden infant death. Reporter''s comment: Autopsy report will be requested when available (expected MAR-2018). Batch no will also be requested. Sender''s comment: Our ref.: 18/45.


VAERS ID: 734999 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-24
Entered: 2018-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Influenza, Pneumonia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK012024

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


VAERS ID: 734864 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA0095075131801CAN009333

Write-up: This spontaneous report as received from a consumer refers to a 14 year old female patient. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (Dose, Lot # and expiry date was not reported) for prophylaxis. On an unknown date, the patient died. The cause of death was not reported. It was unknown if an autopsy was performed. The reporter considered death to be related to GARDASIL. Upon internal review, death was determined to be medically significant. Reported Cause(s) of Death: death.


VAERS ID: 734943 (history)  
Form: Version 2.0  
Age: 0.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:2018-01-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 - / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-01-08
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: PHPFIZERINC2018034808

Write-up: This is a spontaneous report from a contactable other HCP received via a Pfizer sales representative. A 6-month-old patient of an unspecified ethnicity and gender received second dose of PREVENAR 13 at single dose via an unspecified route of administration on 08Jan2018 for immunization. The patient received the vaccination at the health center. Medical history and concomitant medications were not reported. On 08Jan2018, the patient died. It was not reported if an autopsy was performed. Information on the batch number has been requested. Sender''s Comments: The limited information in this report precludes a full assessment of the case. However, per company guidance, "death cause unknown" is processed as "related" until sufficient information becomes available to confirm an unrelated cause of death. Per current information available, patient''s death is more likely due to the underlying medical conditions, but unrelated to the vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: death.


VAERS ID: 735122 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-01-29
Onset:0000-00-00
Submitted: 2018-01-25
Entered: 2018-01-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / IM

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: 2018-01-18
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: SE2018011423

Write-up: This 83-year-old male subject was enrolled in an open label study. The subject received the 2nd dose of Zoster VZV-gE-AS01B (intramuscular) 50 up on 29th January 2011. In December 2017, unknown after receiving Zoster VZV-gE-AS01B, the subject developed severe - grade 3 pneumonia. Serious criteria included death and GSK medically significant. The outcome of pneumonia was fatal on 18th January 2018. The reported cause of death was pneumonia. It was unknown if the investigator considered the pneumonia to be related to Zoster VZV-gE-AS01B. Investigator test: Waiting for Medical records.


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

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

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

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


VAERS ID: 735375 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-25
Entered: 2018-01-26
   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: Death, Multifocal motor neuropathy
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO2018GSK012980

Write-up: This case was reported by a consumer via other manufacturer and described the occurrence of multifocal motor neuropathy in a female patient who received HPV vaccine. On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced multifocal motor neuropathy (serious criteria death and GSK medically significant). On an unknown date, the outcome of the multifocal motor neuropathy was fatal. The reported cause of death was multifocal motor neuropathy. The reporter considered the multifocal motor neuropathy to be related to HPV vaccine. Additional details were provided as follows: The case was received through a video and the video was identified 10 cases of adverse events associated to HPV Vaccine. The age at vaccination was not reported. The patient presented multifocal motor neuropathy and died on an unspecified date. Further information was not expected due to the intermediary refuse to be contacted. This is one of the 10 linked cases reported by same reporter.


VAERS ID: 735429 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-01-25
Entered: 2018-01-26
   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: Death, Scleroderma
SMQs:, Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO2018GSK012979

Write-up: This case was reported by a consumer via other manufacturer and described the occurrence of scleroderma in a female patient who received HPV vaccine. On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced scleroderma (serious criteria death and GSK medically significant). On an unknown date, the outcome of the scleroderma was fatal. The reported cause of death was scleroderma. The reporter considered scleroderma to be related to HPV vaccine. Additional details were provided as follows: The case was received through a video and the video was identified 10 cases of adverse events associated to HPV Vaccine. The age at vaccination was not reported. The patient presented scleroderma and died on an unspecified date. Further information was not expected due to the intermediary refuse to be contacted. This is one of the 10 linked cases reported by same reporter.


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

Administered by: Unknown       Purchased by: Unknown
Symptoms: Back pain, Base excess decreased, Blood bicarbonate increased, Blood cholesterol normal, Blood creatine normal, Blood glucose normal, Blood thyroid stimulating hormone increased, Blood triglycerides normal, Blood urea increased, Brain hypoxia, C-reactive protein normal, Cardiomyopathy, Chest X-ray abnormal, Chronic obstructive pulmonary disease, Crepitations, Death, Decreased appetite, Depression, Dyspnoea, Echocardiogram abnormal, Emphysema, FEV1/FVC ratio, Forced expiratory volume decreased, Forced vital capacity decreased, Haematocrit decreased, Haemoglobin decreased, High density lipoprotein normal, Hypotonia, Insomnia, International normalised ratio decreased, Low density lipoprotein normal, Malaise, PCO2 normal, PO2 decreased, Pericardial effusion, Prostatic specific antigen normal, Pruritus, Pyrexia, Thyroxine decreased, Transient ischaemic attack, White blood cell count increased, pH body fluid normal
SMQs:, Acute renal failure (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amiodarone; mirtazapine; MODURETIC; DUOMO; omeprazole; BAMIFIX; prednisone; DUOFLAN; FLUIR; SPIRIVA; DUOVENT; complex B; FLUIMUCIL; PRELONE; DEPO-MEDROL
Current Illness: 14-SEP-2016, COPD; 14-SEP-2016, Emphysema pulmonary; 14-SEP-2016, Depressive disorder; Drug allergy; Adenocarcinoma of prostate
Preexisting Conditions: Cough; Productive cough; Shortness of breath; Feeling unwell; Smoker, smoked for 40 years-30 cigarettes/day, stopped 6 years ago; DECADURABOLIN; 06-SEP-2015, Chest pain; Cardioversion; 16-SEP-2015, HIXIZINE, pruritus cutaneous; Edema legs
Allergies:
Diagnostic Lab Data: 24-MAY-2016, Blood bicarbonate, 29.5, inconclusive; 17-JAN-2017, Blood cholesterol, 157, inconclusive; 24-MAY-2016, Blood creatine, 0.76, inconclusive; 17-JAN-2017, Blood creatine, 1.22, inconclusive; 17-JAN-2017, Blood glucose, 85, inconclusive; 17-JAN-2017, Blood thyroid stimulating hormone, 107,872, elevated; 17-JAN-2017, Blood triglycerides, 88, inconclusive; 24-MAY-2016, Blood urea, 29, inconclusive; 17-JAN-2017, Blood urea, 30, inconclusive; 24-MAY-2016, C-reactive protein, 6, inconclusive; 17-JAN-2017, FEV1/FVC ratio, 100%, inconclusive; 17-JAN-2017, Forced expiratory volume, 30%, inconclusive; 17-JAN-2017, Forced vital capacity, 31%, inconclusive; 24-MAY-2016, Haematocrit, 38, inconclusive; 17-JAN-2017, Haematocrit, 40, inconclusive; 24-MAY-2016, Haemoglobin, 12.7, inconclusive; 17-JAN-2017, Haemoglobin, 12.3, inconclusive; 17-JAN-2017, High density lipoprotein, 61, inconclusive; 24-MAY-2016, International normalised ratio, 0.28, inconclusive; 17-JAN-2017, Low density lipoprotein, 78, inconclusive; 24-MAY-2016, Oxygen saturation, 95.8%, inconclusive; 24-MAY-2016, PCO2, 43, inconclusive; 24-MAY-2016, PO2, 76.6, inconclusive; 17-JAN-2017, Prostatic specific antigen, 1.430, inconclusive; 17-JAN-2017, Thyroxine, 0.3, inconclusive; 24-MAY-2016, White blood cell count, 11280, inconclusive; 17-JAN-2017, White blood cell count, 8490, inconclusive; 24-MAY-2016, pH body fluid, 7.45, inconclusive. On 23-May-2016, XR HDWC: thorax small atelactasic opacity in the URL causing discrete retention of the parentique side IPSI sequelar aspect discrete broncopathies on ACN bases. Examinations showed: 54.80 KG, BP: 120/80, NSR, 2T, reduction of MV, sparse crepitations. On 08-Aug-2016, examinations showed, 55.25 KG 120/80, NSR, 2T, hypophonese, reduction of MV, rare to sparse crepitations, flat abdomen, flaccid, without organomegaly. On 27-Jan-2017, ECHO showed cardiomyopathy with discrete LV contraction dysfunction, EF-teycholz-54%, LVO-discrete, RV contraction dysfunction F degree discrete-discrete VO, biatrial overload discrete diastolic dynamics, changed relaxation pattern, discrete aortic and mitral reflux, aortic root dilation, pulmonary hypertension - estimated PASP (Pulmonary arterial systolic pressure) between 42 and 47 mmHg, minimal pericardic stroke.
CDC Split Type: 201702712

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


VAERS ID: 735472 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-10-16
Onset:2017-10-16
   Days after vaccination:0
Submitted: 2018-01-26
   Days after onset:102
Entered: 2018-01-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 179901 / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Incorrect route of drug administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-17
   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: candesartan; nebivolol; nifedipine; XARELTO
Current Illness:
Preexisting Conditions: Metastatic melanoma; Dementia; Hypertonia; Apoplexy
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201800140

Write-up: This is a spontaneous case, initially received on 21-Jan-2018, was reported by a physician and concerns a 75-year-old, elderly, male patient. The patient''s historical conditions included metastasizing melanoma, dementia, hypertonia and apoplexy (on unspecified dates). The concomitant medications included candesartan, nebivolol, nifedipine, XARELTO for unknown indications. It was reported that, the patient had was administered FLUAD vaccine in the past and it was tolerated. On 16-Oct-2017, the patient was administered with FLUAD (TIV) (route of administration: subcutaneous, batch number: 179901, dose, anatomical location, expiry date) for an unknown indication (explicitly considered as inappropriate route of vaccination). It was reported that, the vaccine was stored according to the regulations. On 17-Oct-2017, after 2 days of vaccination, the patient passed away (died). The cause of death was not reported. It was unknown whether autopsy was performed. The reporter assessed this case as serious (fatal).


VAERS ID: 735545 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-01-08
Onset:2018-01-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Malaise, Yellow fever
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-01-16
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2018SA017444

Write-up: Initial unsolicited report received from a health care professional via social media on 19-Jan-2018. This case is linked with 2018SA017437, 2018SA017442 and 2018SA017446 (same reporter). This case involves a 76-year-old female patient who was vaccinated with dose of YELLOW FEVER VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 8-Jan-2018. The patient''s medical history, premedication, previous therapy and concomitant medication were not reported. On 09-Jan-2018, one day following the vaccination, the patient already started feeling unwell, with symptoms of the yellow fever. On 16-Jan-2018, eight days following the vaccination, the patient died. The physicians who attended the patient suspected that the patient already had low immunity. It was reported that the death would have occurred due to some immunologic deficiency that was not detected in the screening. It was also reported that the patient did not receive any orientation about not receiving the vaccine in the health clinic. The patient went to a hospital in the region. Lab data and Corrective treatment were not reported. It was not reported whether autopsy was performed or not. It was not reported that if the patient''s physician was aware of this case or not. List of documents held by sender: none. Sender''s Comments: 76-year old female patient developed "symptoms of Yellow fever" 1 day after vaccination with YF vaccine (manufacturer unknown) and died 8 days after vaccination. No information regarding patients medical history was reported, but the attending physician suspected that the patient might have had low immunity prior to vaccination and the death could be related to underlying immunologic deficiency that was not detected. The case was reported from a region, where the outbreak of YF was ongoing. The detailed symptoms are not provided and the diagnosis of yellow fever is not confirmed. There no evidence that would permit to distinguish between wild yellow fever (acquired before vaccination; in incubation period at the time of vaccination) or Yellow Fever Vaccine-associated Acute Viscerotropic disease (YEL-AVD). The patient was at high risk of YEL-AVD due to her age. Lab tests and autopsy results confirming the cause of death, especially specific YF tests with distinction between wild and vaccine strain are needed to ascertain the cause of death. Based upon reported information the role of the vaccine cannot be assessed. Reported Cause(s) of Death: feeling unwell; Symptoms of the yellow fever.


VAERS ID: 736037 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-01-12
Onset:2018-01-15
   Days after vaccination:3
Submitted: 2018-02-02
   Days after onset:18
Entered: 2018-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chills, Death, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-01-15
   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: DE2018GSK017070

Write-up: This case was reported by a consumer via call center representative and described the occurrence of death NOS in a 49-year-old female patient who received Influenza vaccine. On 12th January 2018, the patient received Influenza vaccine. On 15th January 2018, 3 days after receiving Influenza vaccine, the patient experienced death NOS (serious criteria death and GSK medically significant). In January 2018, the patient experienced pain, nausea and chills. On an unknown date, the outcome of the death NOS was fatal and the outcome of the pain, nausea and chills were not reported. The patient died on 15th January 2018. The reported cause of death was death NOS. It was unknown if the reporter considered the death NOS, pain, nausea and chills to be related to Influenza vaccine. Additional details were provided as follows: The GSK employee reported about a colleague. Less than a week after receiving Influenza vaccine, the patient experienced severe pain, nausea and chills over the entire weekend. The patient died due to unknown reason.


VAERS ID: 736085 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-01-16
Onset:2018-01-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2018-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / 2 AR / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Blood test normal, Cyanosis, Death, Pulse absent, Pyrexia, Resuscitation, Sudden infant death syndrome, Toxicologic test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-01-21
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypoglycaemia; Measles; Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GR0095075131801GRC010657

Write-up: This spontaneous report as received from a physician via a company representative refers to a 2 year and 7 months old male patient. In the past, he was administered AMOXIL and had probable allergy to amoxicillin. The patient''s medical history also included measles outbreak and hypoglycaemia episode because he was not properly fed. On an unknown date (reported as at least 2 months before 16-JAN-2018), the patient was vaccinated with M-M-RVAXPRO for prophylaxis. On 16-JAN-2018, the patient was vaccinated with the second dose of VAQTA 0.5 ml (25 U), intramuscularly at the deltoid muscle for prophylaxis. On 20-JAN-2018, the patient experienced fever 38.5 degrees Celsius and NUROFEN was administered. On 21-JAN-2018 at 12:00, he had fever 38.5 degrees Celsius. At 15:00, the mother put the child to sleep and his temperature was 37.6 degrees Celsius. His mother found him lying in prone position with his mouth open and bluish discoloration at face and lips. Resuscitation was performed by a cardiologist during transportation to the hospital. The child was transferred to the hospital warm and with no pulse. General blood tests were performed at the hospital and there were no findings. Mother reported to the physician that according to the autopsy results, death was not related to VAQTA, there were no pathological findings. Sudden death syndrome could not be excluded. Toxicological tests results were pending. The patient died on 21-JAN-2018. The outcome of fever was not reported. The relatedness between the fever M-M-RVAXPRO and VAQTA was not reported. Upon internal review, the event of death was considered to be medically significant. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported serious event of death is considered unlikely related to VAQTA and M-M-RVAXPRO. The evidence is not sufficient to suggest a relationship between the vaccinations and the reported serious adverse event. Causality assessment is impacted by the confounding factor of information reporting that based on autopsy, death was not related to hepatitis A vaccine, inactivated, sudden death syndrome could not be excluded, and history of hypoglycemia episode because of improper feeding. Company Comment- No changes to the VAQTA and M-M-RVAXPRO product safety information are warranted at this time. Merck and Co., Inc., also known as MSD, continues to monitor the safety profile of the products.


VAERS ID: 736089 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-09-25
Onset:2017-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Brain hypoxia, Death, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-01
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis; QT interval prolonged
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2018037902

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 59-year-old female patient of an unspecified ethnicity received PREVENAR 13; (lot number and expiration date were unknown), via an unspecified route of administration, on 25Sep2017 17:00, as single dose for immunization. Medical history included: recurrent bronchitis and asymptomatic QT interval prolonged. The patient''s concomitant medications were not reported. The patient experienced ventricular fibrillation (hospitalized) on 26Sep2017 11:00 and on an unspecified date the patient experienced brain hypoxia. The clinical outcome of ventricular fibrillation and brain hypoxia was fatal. The patient died in Oct2017 with the cause of death reported as ventricular fibrillation and brain hypoxia. It was not unknown if an autopsy was performed. The batch/lot number for the vaccine, Prevenar 13, was not provided and will be requested during follow up. Sender''s Comments: Based on the information currently available, the fatal event "ventricular fibrillation" more likely related to the medical history of asymptomatic QT interval prolonged and fata event "brain hypoxia" is more likely represents a intercurrent medical condition, which considered not related to PREVENAR 13. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: ventricular fibrillation; Brain hypoxia.


VAERS ID: 736308 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2008-10-09
Onset:2008-10-25
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Autopsy, Basilar migraine, Blood brain barrier defect, Blood glucose increased, Brain herniation, Brain oedema, Cardiac arrest, Computerised tomogram normal, Confusional state, Crying, Death, Dizziness postural, Drowning, Drug screen negative, Dysstasia, Gait inability, Headache, Hypoxic-ischaemic encephalopathy, Immediate post-injection reaction, Loss of consciousness, Malaise, Nausea, Neurological examination normal, Resuscitation, Scan normal, Seizure, Speech disorder, Syncope, Toxicologic test normal, Unresponsive to stimuli, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Convulsions (narrow), Dystonia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-12-09
   Days after onset: 45
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: YASMIN
Current Illness: Acne (Stop Date: Continuing); Allergy to animal (Stop Date: Continuing); Iodine allergy (Stop Date: Continuing); Migraine (Stop Date: Continuing); Pollen allergy (Stop Date: Continuing); Prophylaxis; Renal cyst (Stop Date: Continuing)
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine (Medical History Comment: also migraine in family history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA0095075130902CAN00119

Write-up: Information received regarding a case in litigation from a lawyer, an Agency, a nurse, physician, patient''s (Pte) mother and news report concerning a 14 year old healthy female with occasional and well controlled migraine and acne who on 09-OCT-2008, was vaccinated with the first dose of GARDASIL, lot # not available. Concomitant Tx included hormonal contraceptives. New information received on 05-MAR-2009 from a physician who reported that in October 2008 the pte received the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine, lot # not available. In approximately October 2008 the pte had convulsions and was investigated in hospital. Nothing was found. It was reported that an autopsy was conducted and results expected by approximately 15-APR-2009. New information received on 26-MAR-2009 from the pte''s mother via a news report; on approximately 24-OCT-2008 the pte was found to be completely lost did not know her name, could not stand up, could not speak. The pte was taken to the bathroom by her mother and compress was applied. The pte''s mother at first felt that her daughter had taken drugs or had an overdose daughter was not the type to take drugs. The pte remained unresponsive and emergency services were called by mother. The pte started to respond after 25 minutes she was able to recall her name. The mother called infoHealth and was recommended to take her daughter to the hospital. The pte started to vomit upon arrival at the hospital, approximately 25 times. The pte remained under observation overnight. The following morning the pte was tested for drugs but was found clean. The pte was also examined by the neurologist and neurological exams were performed hands, to verify if there was brain damage or something else and found to be normal. The diagnosis was that the pte had a basilar migraine. The mother did not agree with the diagnosis since she also experienced migraines as well as her mother and felt it was genetic. The mother insisted that her daughter have a scan which was normal. Subsequently the pte was fine as if nothing had happened. The pte was recommended to stop taking birth control pill for her acne which was done on the day she was discharged from hospital. The pte updated her health profile at school and if the symptoms recurred she was to call emergency services. On 23-NOV-2008 the pte was vaccinated with second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine, lot # not available. The mother reported that no thought was given to the vaccine, not even at the hospital no details provided. On 09-DEC-2008, 15 days after second dose, the pte arrived from school had dinner, watched TV and at 19:00 went to take a bath. The pte did not respond to her mother. The mother broke down the door and found her daughter had drowned in the bath. The mother reported she was 10 feet from her daughter and did not hear anything not even a call for help. There was no trace of violence. The mother reported that she spoke to the coroner several times since she thought her daughter had drowned. The coroner confirmed that the pathologist had said no. The pte had not drowned since there was not enough water in her lungs. The primary autopsy showed no significant findings, the cause of death was unknown. Further analysis to be done, results might take up to six months (no details provided). The mother reported that she had seen an article in the newspaper on 11-FEB-2009 about two girls in another country that were hospitalized regarding the vaccine where the lots were recalled. The mother linked those two cases with the fact that her daughter had received the same vaccine. The mother requested her daughter''s school health record and spoke to the school nurse. The school nurse confirmed that the pte previously updated her health record. New info has been received 12-OCT-2009 by email stating that the pathologist''s conclusion was that the death was sudden and unexplained. He specifically mentioned that "we did not see any anatomopathological evidence of abnormal reaction that would suggest a link between Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine and this case of sudden death. New info has been received on 14-DEC-2010 in form of a coroner''s investigation report with the following details: Date of Death: 09-DEC-2008 at 20:32. Probable Cause of Death: Drowning. Identification: The youth was identified by her mother at the hospital in the presence of personnel. External Examination: On the external examination performed at time of the autopsy, there was absence of traumatic lesions on the body. Internal Examination: On 17-DEC-2008 autopsy performed. The pathologist''s exam did not identify a precise cause of death. There were no anatomopathological or microbiological observations, nor an inflammatory reaction to explain this death. The changes observed in the brain by a neuropathological exam, or in the lungs, were probably secondary to the terminal process. Prior History: This youth was known for renal cyst, headaches, also reported as migraines and allergies to certain substances such as iodine, animals and pollen. Other Reports: A toxicological analysis of biological samples was negative. Circumstances of Death: On 09-OCT-2008 the young pte received her first Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine vaccination under an adolescent vaccination program. The pte was taking the contraceptive YASMIN for an acne problem since 2 months, as a replacement for another medication, no further details. On 25-OCT-2008 the pte was crying in her room. When her mother spoke to her, she was confused, vomited and had intense headaches, worse than what she was used to having. The pte was brought to the hospital emergency. Upon examination the pte said she was weak, dizzy upon standing, unable to walk, and nauseated. Blood sugar was 6.6. Pte was kept for observation. On 26-OCT-2008 CT scan results were within normal limits. The pte was diagnosed with basilar migraines and was discharged. It should be noted there was no mention of the pte recent vaccination. In the followup health form completed on 12-NOV-2008, the problem of basilar migraines was recorded. It was recommended to call 911 to be brought to the same hospital if the situation reoccurs. On the pre-immunization questionnaire, basilar migraines in October 2008 and flu vaccination in November 2008 were recorded. On 24-NOV-2008 the pte received second dose of Quadrivalent Human Papillomavirus Types 6,11,16,18) Recomb. Vaccine. On 09-DEC-2008, young pte returned from school around 17:10. She went into the bathroom around 19:15. Around 19:50 the mother found that too much time has passed and called her daughter who did not respond. The mother opened bathroom door and found her daughter unconscious with her head on the side and under the water. The mother released the posterior portion of her daughter''s body and ran to advise her spouse. He was outside, but came right away to help. They took the body out of the bath and called 911. Resuscitation maneuvers were undertaken. Ambulance technicians were first to arrive on the scene at 19:54. The pte did not have vital signs and upon ventilation they noticed the presence of water mixed with food. The police also arrived on the scene. The pte was transported urgently by ambulance to the hospital, where she was admitted at 20:21 by the emergency team. Asystole persisted despite advance cardiopulmonary resuscitation was stopped at 20:32. The physician pronounced the pte dead. The diagnostic impression was drowning secondary to sudden loss of consciousness. It is a little surprising to note that autopsy was not conclusive of drowning. This perhaps could be explained by the fact the autopsy was performed 7 days after the death. This was explained by the fact that the body was presented to a pathologist who refused to perform the autopsy for reasons according to him that an autopsy performed under pediatric specialty would be more appropriate. At the time of this refusal, a number of days had already passed since death. The autopsy physician indicated in report that postmortem changes of the collective organs limited her histologic exam. This exam is useful amongst other things to complement the microscopic exam. The study of the different specimens under microscope could confirm or invalidate what was seen in the autopsy, or reveal what naked eye could not perceive. The investigation concluded that it was a circumstantial drowning. There was emesis which could be compatible with drowning even if she could have had an episode of a convulsion. The ambulance technicians noted the presence of water and food at the time of respiratory ventilation. Consequently, her death resulted from a natural accidental cause in the absence of evidence of intervention by a third party, or a gesture of self destruction. It is clear that she experienced loss of consciousness or syncope when she was in the bath. It cannot be explained otherwise the fact that her head was under water. It could be that cardiac, neurological, glycemic, hydroelectrolytic, etc. events occurred without being able to detect their trace. This is what is identified as a sudden death which could occur at any age. The mother did not accept her daughter died without any known reason and this is legitimate. She points therefore to the vaccination with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine as responsible for the death of her daughter who in the first place had a reaction about 15 days after having her first dose where medicine could not give valid explanation for her daughter''s malaise. In the second place, about 15 days after her second vaccination, her daughter died and once again, medicine could not provide valid explanation. She could only associate the vaccination with the death. The pathologist indicated that there was no anatomopathological evidence of abnormal reaction to establish a link between the vaccination with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine and the pte''s death. New information on 21-DEC-2010 in form of internet news report of the coroner''s report which included that it was a death by drowning, and does not prove without a doubt that administration of the vaccine caused the death of this adolescent, however, the coroner refused to draw a link with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine to explain it. The coroner speaks in his report of a natural death which cannot be explained. New information received on 22-DEC-2010 in form of internet newspaper article on the coroner''s report which included the following: She had received the second of two doses required for the HPV vaccination on 24-NOV-2010. The coroner''s report did not make a direct link between the pte''s death and the Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine vaccination she had received days earlier. The pte''s death is the first since the province set up a provincial HPV vaccination program in September 2008 for girls in Grades 4 to 9. While the coroner ruled accidental drowning was the immediate cause of the pte''s death, he went on to say in the report released yesterday that the contributing factors are far less clear. If the probable cause of death is known, the reasons for it are far from known. He noted the pte had been rushed to the hospital 26-OCT-2008, suffering headaches, confusion and vomiting. She underwent series of tests and was released with a diagnosis of migraine headaches, reported as basilar migraines in the actual coroner''s report. At that time, there was no mention of the dose of HPV she had received on 09-OCT-2008. The coroner''s report noted that a similar adverse reaction likely preceded the pte''s death because ambulance attendant reported vomit in the tub when the pte died. In addition, the coroner noted that the teenager had been taking the oral contraceptive drospirenone (plus) ethinyl estradiol to treat acne, and what link exists there, is also unknown .New information received from the Agency (# 000358593) with following events: abasia, asthenia, basilar migraine, blood glucose increased, cardiac arrest, confusional state, dizziness postural, drowning, loss of consciousness, nausea, syncope and vomiting. This was originally reported by a coroner/medical examiner. It was reported that a causal relationship was suspected between therapy with drospirenone (plus) ethinyl estradiol and the events. Agency considered the events to be serious and were considered to be other important medical events. New information received on 26-JAN-2012 from a lawyer including the following: On 25-OCT-2008 around 21:30, the pte was checked by a doctor at hospital emergency who recorded on the pte medical file. Reason for consultation: migraine plus vomiting plus confusion. History: 14 year old girl. Known as having migraine. That evening, pte was reading on her bed, was found crying, understandable, speech (unreadable), vomited in her bed and 2 times in the toilet. Confused for 30 minutes with slow improvement. Pte had no memory of the episode. Intense migraine. Not similar to the usual migraine .No fever. No drugs. No infectious contact. No loss of consciousness. No neurofacial symptoms. Otherwise good that day, no symptoms of upper respiratory tract infection. No fall/trauma. No alcohol. Not active sexually. Medications: drospirenone (plus) ethinylestradiol. Medical history: migraine. Family history: migraine. Allergy: Iode. Glasgow Coma Scale (GCS) 15/15. Heart B1/B2 normal. B3/B4 murmur. Tachycardia 120. Normal ROT and symmetric. Strength 2/5 DOR 4 members and Pte dizzy when standing up. Finger nose normal (slow but precise). Migraine or illicit drugs or hypoglycemia or intracranial process (mass, bleeding). Neurologist consultation in the morning. New information received on 31-JAN-2012 in the form of an internet newspaper article which stated that the pte was seen in consultation on 04-NOV-2008 by her family doctor (No details provided). New information received on 20-FEB-2012 stating that Information has been received from a consumer, as part of a marketing research program conducted concerning a 14 year old female who on an unspecified date was vaccinated with the second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (Lot # unknown). The consumer reported that the pte who was a friend of her daughter died suddenly 2 weeks after receiving the second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine. Follow up information has been received from a blog on the internet in which the pte''s mother reported that her daughter died post Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine vaccination. The mother stated that her daughter received the vaccine at school. This is a consolidation of 2 reports for the same pte. Update (09-JUL-2012): Lot numbers were provided: NG31270 and NG09700. This is an amended case. Batch # NG31270 was entered to coincide with Lot # 658219/0817U (expiry date: 16-MAR-2010) and batch # NG09700 was entered to coincide with Lot # 658216/0735U (expiry date: 14-MAR-2010). Prophylaxis was entered into the Reported Indication field to replace acne. New information received on 01OCT2012: This spontaneous report was received from a website. In October 2008 the first injection (intramuscular) of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine for human papilloma virus was performed. After the first injection of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine in the hospital the pte felt bad (not specified). The pte was diagnosed with migraine (date not specified) and was discharged from the hospital. In November 2008 the second Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine injection was performed and the pte felt bad again. Two weeks after the pte was found dead. As it was reported the pte died on 09-DEC-2008. Update (02OCT2012): On 02OCT2012, the full translation of the article from a website was received. GARDASIL a widely Advertised papilloma vaccine has killed lots of people 25-SEP-2012. Pte, born 1993, died after a shot of GARDASIL against the human papilloma virus. Her death occurred on 09-DEC-2008, after two GARDASIL doses were administered within the framework of the program implemented by the provincial government. Pte''s mother reported that the first injection her daughter had received in the clinic in October, 2008 and immediately felt unwell. The diagnosis pronounced was migraine and the girl was released home. After the second dose of GARDASIL in November, 2008 her condition worsened, and two weeks later her parents found her dead in the bathroom. Update (06-NOV-2012) Literature report: The autopsy failed to identify a precise cause of death. In particular, there were no anatomical, microbiological nor toxicological findings that could explain this case of death which was classified as sudden and unexpected death. Nonetheless, autopsy revealed cerebral edema and cerebellar herniation indicative of a focally disrupted blood brain barrier. Although no specific antibodies to inflammatory markers were used in IHC analysis of brain sections, the autopsy reported that there was no evidence of inflammatory processes or microglial reactions in the pte''s brain. There were however acidophilic changes of the Purkinje cells in the cerebellum with vacuolation of the overlying molecular layer. According to the coroner, these changes were consistent with terminal ischemichypoxic encephalopathy. Neuropathological examination did not demonstrate an underlying structural brain disorder. In addition, the coroner''s report commented that the ischemichypoxic encephalopathy was terminal as was the cerebral edema and that either one could have been caused by the other. Based on the autopsy findings, the coroner was unable to establish a precise sequence of events and the specific etiology remained undetermined. Conclusions: Our study suggests that HPV vaccines containing HPV-16L1 antigens pose an inherent risk for triggering potentially fatal autoimmune vasculopathies. Follow-up information was received from a non-healthcare professional via a newspaper article on 24-JAN-2018. On 25-OCT-2008, the patient came out of the room disoriented, could hardly walk, could not speak and was mumbling. Causality was reported as related for all the events. It has been determined that case # CA-009507513-1801CAN009333 is a duplicate of case # CA-MERCK-0902CAN00119. Therefore, case # CA-009507513-1801CAN009333 is being deleted from our files and the cases are consolidated into case # CA-MERCK-0902CAN00119. Sender''s Comments: MERCK 0902CAN00119: Mfr number; Autopsy-determined Cause(s) of Death: Drowning.


VAERS ID: 736311 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / UN

Administered by: Unknown       Purchased by: ?
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: 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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131802DEU001356

Write-up: Information has been downloaded from Regulatory Authority (DE-GLAXOSMITHKLINE-DE2018GSK007466). This spontaneous report as received from a physician refers to a 1 year old patient. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with VARIVAX for prophylaxis (dose, frequency, route were not provided). Other suspect therapy included PRIORIX for prophylaxis (dose, frequency, route were not provided). On an unknown date, the patient had pyrexia and died on an unknown date due to an unknown cause (the outcome of pyrexia was also reported as unknown). It was unknown if an autopsy was performed. The causality assessment was not provided by the reporter.The events were considered serious due to hospitalization and death. The Agency considered the events to be medically significant.


VAERS ID: 736372 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Death, Dysphagia, Dyspnoea, Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Muscle atrophy, Muscular weakness
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Demyelination (narrow), Respiratory failure (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2018SA010915

Write-up: Based on information received on 11-Jan-2018, suspect vaccine was amended from STAMARIL to YELLOW FEVER VACCINE. Initial unsolicited report received from consumer (unspecified relationship with the patient) through social media on 11-Jan-2018. This case involves a male patient of unknown age who was vaccinated with YELLOW FEVER VACCINE (Manufacturer unknown) (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient''s medical history, premedication, previous therapy and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed Guillain-Barre syndrome and an unspecified damage due to which the patient was died on an unspecified date. Laboratory investigations and corrective treatments were not reported. Outcome of the event Guillain-Barre syndrome was not reported at the time of reporting. Upon internal review, the company decided to consider the event serious because of important medical event Guillain-Barre syndrome. The case was also considered as serious as the patient was died. It was not reported if the patient''s physician was aware of this case. It was not reported if autopsy was performed or not. Follow up report received from consumer or non-healthcare professional (unspecified relationship with the patient) through Digital Media on 17-Jan-2018. This case is linked with 2018SA015070 (same reporter). It was informed that, in 2009, the 33 years old patient received the vaccination with YELLOW FEVER VACCINE through a Governmental campaign, due to an outbreak of yellow fever in the region where the patient lived. On an unspecified date in 2009, five days after the vaccination, the patient started to experience numbness, weakness on arms, weakness on legs, difficulty to breath, and difficulty to swallow. On an unspecified date in 2009, the symptoms worsened (ADR) and the patient received the diagnosis of Guillain-Barre syndrome, as previously reported. This condition was confirmed through specific exams performed in a regional hospital. The patient spent months in the Intensive Care center, with progressive muscle loss. The patient''s wife started to take care of him, but the patient died after three cardiorespiratory arrests, five months after he was vaccinated (estimated by 2009). Initially, as corrective treatment, the patient was just medicated with unspecified medications. It was reported that, according to the patient''s wife''s lawyer, if the patient was vaccinated up to 30 days before the diagnosis of Guillain-Barre syndrome, it must have been related to the vaccine, without any doubt. On the other hand, it was reported that the Health Ministry informed that the vaccine was safe, and the patient''s case was studied by the Vaccine Pharmacovigilance Institutional Committee, and the analysis did not reach a conclusive result; it did not confirm nor discarded the association of the syndrome to the vaccine Documents held by sender: none. Addendum: Based on information received on 11-Jan-2018 and 17-Jan-2018, the following information were amended: Suspect drug changed from company vaccine (STAMARIL) to Yellow fever vaccine (mfr unk). Social media was changed to Digital medial and the details of digital media were updated. Sender''s Comments: Follow up information received on 17-JAN-2018 changes the medical assessment of the case as follows: This is a retrospective (2009) medically unconfirmed case, reported from social media. Reportedly, the patient developed Guillain-Barre syndrome with numbness, weakness of limbs, difficulty breathing, difficulty swallowing after vaccination with Yellow fever vaccine (Mfr Unk). Patient developed the symptoms 5 days after vaccination and his condition worsened with time. Patient had progressive muscle atrophy and died after three cardiorespiratory arrests. It is to be noted that Vaccine Pharmacovigilance Institutional Committee who was studying the patient''s case did not confirm nor did discard the association of the syndrome to the vaccine. Patient''s medical history, immune status at the time of vaccination, vaccine manufacturer, results of investigations (confirmatory lab tests for the diagnosis of GBS and autopsy reports) are needed to further assess this case. Based upon reported information the role of the vaccine cannot be assessed. Reported Cause(s) of Death: Unspecified damage; Cardio-respiratory arrest; Guillain-Barre syndrome.


VAERS ID: 736418 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2018-01-05
Onset:2018-01-14
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-01-15
   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:
Current Illness: Lung cancer
Preexisting Conditions: Medical History/Concurrent Conditions: Oxygen therapy (domiciliary oxygen therapy); Radiotherapy (Lung small cell carcinoma)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2018037186

Write-up: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 73-year-old patient of an unspecified ethnicity and gender received PREVENAR 13, (lot number: unknown) intramuscular at single dose on 05Jan2018 for immunisation. Medical history included ongoing lung neoplasm malignant, and radiotherapy from an unknown date and unknown if ongoing for lung small cell carcinoma. The patient was under domiciliary oxygen therapy. Concomitant medications were not reported. 1 week later, on 14Jan2018, the patient experienced radiation pneumonia which was classified serious with outcome of death as of 15Jan2018. Cause of death was reported as radiation pneumonia. It was not reported if an autopsy was performed. The reporter considered the event was unrelated to pneumococcal 13-val conj vac (dipht crm197 protein) because antibody was not generated as it had only been 1 week after vaccination. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Sender''s Comments: In concurrence with the reporting physician, the reported fatal event radiation pneumonia is considered not related to the use of PREVENAR 13 but more likely related to the underlying medical condition radiotherapy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: Radiation pneumonia.


VAERS ID: 736536 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antimicrobial susceptibility test resistant, Antimicrobial susceptibility test sensitive, Death, Meningitis, Minimum inhibitory concentration, Streptococcus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congenital hydrocephalus (congenital hydrocephalus with ventriculoperitoneal shunt); Ventriculo-peritoneal shunt
Allergies:
Diagnostic Lab Data: Test Name: Antimicrobial susceptibility test; Result Unstructured Data: Test Result: Susceptible; Test Name: Antimicrobial susceptibility test; Result Unstructured Data: Test Result: Resistant; Test Name: Antimicrobial susceptibility test; Result Unstructured Data: Test Result: Intermediate resistance; Test Name: Minimum inhibitory concentration; Test Name: Serology test; Result Unstructured Data: Test Result: 19 F
CDC Split Type: TRPFIZER INC2018025950

Write-up: The initial case was missing the following minimum criteria: an unspecified suspect product. Upon receipt of follow-up information on 24Jan2018, this case now contains all required information to be considered valid. This is a literature study report. This author reported similar events for two different patient. This is the first of two reports referring to patient 5 of table 1. A breakthrough infection occurring with 13-valent pneumococcal conjugate vaccine (PCV13) are previously described. A breakthrough infection is defined as invasive pneumococcal disease (IPD) in a child who had received 1 PCV-7 or PCV-13 and for which the pneumococcal isolate was a vaccine serotype. During one year period, among 6 patients with invasive pneumococcal infection, 2 patients were considered to have a vaccine failure with serotype 19F. Antibiotic resistance results were remarkable; macrolide resistance were observed in all strains except one, and high and intermediate penicillin resistance were determined in 2 strains. Author''s hospital is a tertiary referral hospital and the department has led an analysis of hospital-based pneumococcal surveillance across area since 2008. The medical records of cases aged less than or equal to 18 years and diagnosed with IPD by pediatric infectious disease specialists between Jan2015 and Jan2016 at Hospital were retrospectively reviewed. The study was approved by the Ethical Committee. IPD cases were eligible for evaluation if S. pneumoniae had been isolated from a normally sterile body site. The data for age, gender, underlying diagnosis, type of pneumococcal clinical syndrome, serotype, antibiotic susceptibility of the bacteria to penicillin, immunization status of the patients with regard to pneumococcus, length of treatment, and length of hospital stay were obtained. The isolates were subjected to disc susceptibility tests for penicillin, macrolides, and fluoroquinolones, according to the guidelines of the Clinical and Laboratory Standards Institute. Minimum inhibitory concentration (MIC) was established using an Epsilometer test (E-test, Biomerieux, S.A.S.). All of the patients diagnosed with IPD were identified as male, with a median age of 28 months (a range of 2-61 months) during the study period, from Jan2015 to Jan 2016. Underlying disease was found in all of the patients, with the exception of 2 (cases 1 and 2). One of the patients with oncological malignancy (case 3) was undergoing chemotherapy. The other diagnoses were inherited metabolic disorder (case 4), congenital hydrocephalus with ventriculoperitoneal shunt (case 5), and cerebral palsy secondary to intracranial bleeding (case 6). Three patients presented with meningitis (cases 1, 2 and 5), 2 patients with bacteremia (cases 3 and 4), and one with pneumonia (case 6). It was found on investigation into the patients'' immunization status that the one with oncological malignancy had not received a pneumococcal vaccination. Two patients (cases 5 and 6) had been vaccinated with 3 doses of 13-valent pneumococcal conjugate vaccine (PCV13) and one (case 2) with 3 doses of the 7-valent pneumococcal conjugate vaccine (PCV7). All three patients had received a booster dose. Two patients, aged 2 months (case 1) and 8 months'' (case 4) had received a single dose of PCV13 and 3 doses of PCV13, respectively. All of these vaccinations had been administered appropriately in accordance with their ages. The median length of antibiotic treatment was 16 d (minmax = 6-24 months) and the median length of hospitalization was 28.5 d (min-max = 6-48 days). At the end of treatment, for 2 cases (case 5 and 6) the outcome was fatal where for 2 meningitis cases (case 1 and 2) neurologic sequelae occurred. Serotype 19F was observed following an investigation into cases 5 and 6 and attributed to vaccine failure. High and intermediate resistance to penicillin was observed in 2 cases. Antibiotic susceptibility and the individual MIC values are demonstrated. Macrolide resistance was observed in all strains, except one. Fluoroquinolone resistance was not found in any of the strains. Although only a small number of patients were included in the study, since the hospital is a referral hospital, the data are invaluable in highlighting severe IPD cases in the region. The most prevalent clinical syndrome was meningitis, followed by bacteremia and sepsis. Non-vaccine serotypes (15B, 18F, and 1) were found in 4 of the cases, drawing attention to the emergence of non-vaccine serotypes as the cause of IPD. Two of the patients in the current study who had completed the age-appropriate PCV13 vaccine series acquired serotype 19F, indicative of a vaccine breakthrough. Underlying neurological diseases were present in both of these patients who died during treatment. Fluoroquinolone resistance was not demonstrated in any of the pneumococci in the present study, whereas macrolide susceptibility was found in a single strain. Intermediate and high resistance to penicillin was observed in 2 patients. Rational antibiotic usage in clinical practice is urgently required since the percentage for the prevalence of pneumococcal antibiotic resistance is higher than that reported in area. In conclusion, greater efforts are required to combat S. pneumoniae. Proper diagnosis of IPD cases, definition of microbiological characteristics of pneumococci, and follow up of disease prognosis are crucial steps for improving the knowledge of the emerging serotypes, determination of their invasive disease potentials, and revealing vaccine failure. This study findings were invaluable in highlighting aforementioned features of IPD in the region. Still larger, more extensive surveillance studies are required to corroborate the results for planning effective vaccination strategies. The characteristics of the patient 5 with invasive pneumococcal disease was as follow: The patient was 13 month old male, underlying diagnosis includes Hydrocephalus with VP shunt. The patient received 4 doses of pneumococcal 13-val conj vac (dipht crm 197 protein) on unspecified dates. The patient developed meningitis on an unknown date and Serotype of pneumococcus 19F was isolated and attributed to vaccine failure. The patient was hospitalized and treated for 6 days. Antibiotic susceptibility profiles revealed: Penicillins: Intermediate resistance, Macrolides: Resistant, and Fluoroquinolones: Susceptible. The patient died on an unknown date. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm 197 protein) in the reporter''s country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm 197 protein) has submitted the same report to the regulatory authorities.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : TR-PFIZER INC-2018034414 Same article/drug/event, different patient; Reported Cause(s) of Death: vaccine failure with serotype 19F; Meningitis serotype 19F.


VAERS ID: 736769 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131802DEU003525

Write-up: This spontaneous report was received from a physician via a company representative regarding a female patient of unknown age. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot # and expiry date was not reported) for prophylaxis. On an unknown date, the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. The reporting physician did not provide the causality assessment for the event. The event was considered to be serious due to death. Upon internal review, death was determined to be medically significant. Reported Cause(s) of Death: unknown.


VAERS ID: 737591 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-06-22
Onset:2017-06-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC868 / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S22735 / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M040264 / 2 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Apnoea, Atelectasis, Auditory disorder, Autopsy, Basal ganglia haemorrhage, CNS ventriculitis, Cardiac failure, Cerebral palsy, Child maltreatment syndrome, Citrobacter infection, Crying, Death, Decreased appetite, Dysphagia, Enterobacter infection, Epilepsy, Hypoxic-ischaemic encephalopathy, Illusion, Irritability, Meningitis, Poor quality sleep, Respiratory arrest, Restlessness, Resuscitation, Retinal haemorrhage, Seizure, Subdural haematoma, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Akathisia (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (narrow), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Retinal disorders (narrow), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2018-01-30
   Days after onset: 222
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: Early onset neonatal sepsis; Extreme immaturity, 1,500-1,749 grams (birth-weight: 1600g); Prophylactic vaccination; Surfactant deficiency syndrome neonatal; Twin pregnancy (Twin pregnancy, former twin miscarriage 33 + 2)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131802DEU003338

Write-up: Information has been downloaded from database (DE-PEI-PEI2018000302) on 05-FEB-2018. This spontaneous report as received from a physician refers to a 2-month-old male patient (twin pregnancy) (premature baby, extreme immaturity, 1500-1749 grams, former twin miscarriage 33 + 2) with sepsis neonatal and surfactant deficiency syndrome neonatal (1 time received surfactant, otherwise an unsuspicious course). The patient was administered 5 days pharyngeal respiratory support in the context of onset sepsis. After discharge no diseases. The day before hospitalization the second vaccine was received, according to the mother crybaby. On 22-MAY-2017, the patient received the first dose of ROTATEQ, INFANRIX HEXA and PREVENAR 13 (transmitted as historical drugs). On 22-JUN-2017, the patient was vaccinated with the second doses of ROTATEQ (lot # M040264, expiry date: 31-MAY-2018, orally), INFANRIX HEXA (batch: A21CC868) and PREVENAR 13 (batch: S22735). On 22-JUN-2017, the patient experienced poor quality sleep, decreased appetite, seizure, respiratory arrest, apnoea, restlessness, crying, irritability and vomiting. On 23-JUN-2017, the patient experienced child maltreatment syndrome, cardiac failure, atelectasis, meningitis, cns ventriculitis, resuscitation, citrobacter infection, acute respiratory failure and seizure. On 24-JUN-2017, the patient experienced retinal haemorrhage. On 11-AUG-2017, the patient experienced hypoxic-ischaemic encephalopathy, epilepsy, auditory disorder, cerebral palsy, subdural haematoma, subdural haemorrhage , cerebral haemorrhage, enterobacter infection, illusion, dysphagia and basal ganglia haemorrhage. Due to all event the patient was hospitalized. The patient died on 30-JAN-2018. Autopsy was performed, but result was not available. The outcome for all events was reported as unknown, however death was checked as seriousness criteria for all adverse events. Relatedness between all events and the vaccination with ROTATEQ was not reported. All event were assessed to be life-threatening. Reported Cause(s) of Death: Death.


VAERS ID: 737983 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-02-16
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MX2018GSK025569

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of death in a female patient who received HPV vaccine. On an unknown date, the patient received HPV vaccine at an unknown dose. On an unknown date, unknown after receiving HPV vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to HPV vaccine. Additional details were provided as follows: The age at vaccination was not reported. This information was received from digital news article. On unspecified date, it was reported that a girl died because of unspecified HVP vaccine application. As the information was received through digital newspaper, follow up could not be performed. Case was considered as close. No more information was available. This case has been linked to the MX2018GSK025567 and MX2018GSK025571, reported by the same reporter.


VAERS ID: 737985 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-02-16
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amnesia, Anaphylactic reaction, Coma, Drug reaction with eosinophilia and systemic symptoms, Immunoglobulin therapy, Injection site reaction, Petit mal epilepsy, Stevens-Johnson syndrome
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MX2018GSK025571

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of Stevens Johnson syndrome in a 10-year-old female patient who received HPV vaccine. In October 2017, the patient received HPV vaccine. In October 2017, 2 hrs after receiving HPV vaccine, the patient experienced absence seizure (serious criteria GSK medically significant). On an unknown date, the patient experienced Stevens Johnson syndrome (serious criteria death and GSK medically significant), injection site reaction (serious criteria hospitalization), dress syndrome (serious criteria hospitalization), coma (serious criteria GSK medically significant), anaphylaxis (serious criteria GSK medically significant) and memory loss. The patient was treated with Gamma Globulin Human, Antibiotics (Drug Name Unknown) and Anticonvulsant. On an unknown date, the outcome of the Stevens Johnson syndrome was fatal and the outcome of the absence seizure, injection site reaction, dress syndrome, coma, anaphylaxis and memory loss was unknown. The patient died in February 2018. The reported cause of death was Stevens Johnson syndrome. The reporter considered the Stevens Johnson syndrome, absence seizure, dress syndrome, coma, anaphylaxis and memory loss to be unrelated to HPV vaccine. It was unknown if the reporter considered the injection site reaction to be related to HPV vaccine. Additional details were provided as follows: This information was received from digital news article. The patient presented absence seizure crisis. On an unknown date, less than a year after HPV vaccine, the patient presented memory loss and skin reactions at the application site. The patient received antibiotic and anticonvulsant treatment prior to hospital admission and it was considered that the combination of both treatments caused anaphylaxis. On 23rd December 2017, the patient arrived at the intensive care unit and was diagnosed with DRESS syndrome which progress to Stevens-Johnson syndrome. As treatment, the patient received human gamma globulin. On an unknown date, less than a year after HPV vaccine, the patient stayed in an induced coma. The patient''s relative''s mentioned that she did not present any apparent pathological data before the vaccine application. In February 2018, the patient died. The hospital director mentioned that the HPV vaccine was not related with the symptoms that the patient presented and the reactions were depend on her susceptibility, not on the vaccine. As the information was received through digital newspaper, follow up could not be performed. No more information was available. This case has been linked to the MX2018GSK025567 and MX2018GSK025569, reported by the same reporter.


VAERS ID: 738220 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-10-25
Onset:2017-11-14
   Days after vaccination:20
Submitted: 2018-02-16
   Days after onset:94
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-14
   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: DE2018GSK025867

Write-up: This case was reported by a physician and described the occurrence of bronchitis in a 94-year-old female patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). On 25th October 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 14th November 2017, 20 days after receiving INFLUSPLIT TETRA, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the patient experienced bronchitis (serious criteria death). The patient was treated with azithromycin. On 14th November 2017, the outcome of the bronchitis was fatal. On an unknown date, the outcome of the stroke was not recovered/not resolved. The patient died on 14th November 2017. The reported cause of death was bronchitis. An autopsy was not performed. It was unknown if the reporter considered the bronchitis to be related to INFLUSPLIT TETRA. The reporter considered the stroke to be unlikely related to INFLUSPLIT TETRA. Additional details were provided as follows: The patient had no underlying disease or risk factors. The patient received INFLUSPLIT TETRA in the left upper arm. Less than a month after vaccination, the patient experienced bronchitis. Bronchitis was reported as cause of death. Treatment was not performed. The start date for bronchitis was reported. This is 1 of 9 cases, reported by the same reporter.


VAERS ID: 738255 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-02-16
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MX2018GSK025567

Write-up: This case was reported by a consumer via interactive digital medial and described the occurrence of death in a male patient who received HPV vaccine. On an unknown date, the patient received HPV vaccine at an unknown dose. On an unknown date, unknown after receiving HPV vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to HPV vaccine. Additional details were provided as follows: The age at vaccination was not reported. This information was a digital news article. On unspecified date, it was reported that a boy died because of unspecified HPV vaccine application. As the information was received through digital newspaper, follow up could not be performed. Case was considered as close. No more information was available. This case has been linked to the MX2018GSK025569 and MX2018GSK025571, reported by the same reporter.


VAERS ID: 738256 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-06
Onset:2017-11-22
   Days after vaccination:16
Submitted: 2018-02-16
   Days after onset:86
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-22
   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; Amlodipine; Clopidogrel
Current Illness: Renal failure, grade III; Hypertension; Anaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK025850

Write-up: This case was reported by a physician and described the occurrence of stroke in a 81-year-old male patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). Concurrent medical conditions included renal insufficiency (grade III), hypertension and anemia. Concomitant products included ramipril, amlodipine and clopidogrel. On 6th November 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 22nd November 2017, 16 days after receiving INFLUSPLIT TETRA, the patient experienced stroke (serious criteria death and GSK medically significant). On an unknown date, the outcome of the stroke was fatal. The patient died on 22nd November 2017. The reported cause of death was stroke. An autopsy was not performed. The reporter considered the stroke to be unlikely related to INFLUSPIT TETRA. Additional details were provided as follows: Ramipril, Amlodipine and Clopidogrel were applied permanently. The patient received INFLUSPLIT TETRA on the left upper arm. No treatment was performed. This is one of the 9 linked cases reported by same reporter.


VAERS ID: 738258 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-22
Onset:2017-12-02
   Days after vaccination:10
Submitted: 2018-02-16
   Days after onset:76
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Intensive care, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-04
   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: Spironolactone; Bisoprolol; ASA
Current Illness: Diabetes mellitus; Hypertension
Preexisting Conditions: 2015, Cerebrovascular accident
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK025817

Write-up: This case was reported by a physician and described the occurrence of myocardial infarction in a 81-year-old male patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). The patient''s past medical history included stroke. Concurrent medical conditions included diabetes (type IIB) and hypertension. Concomitant products included spironolactone, bisoprolol and ASA. On 22nd November 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 2nd December 2017, 10 days after receiving INFLUSPLIT TETRA, the patient experienced myocardial infarction (serious criteria death, hospitalization and GSK medically significant). On 4th December 2017, the outcome of the myocardial infarction was fatal. The patient died on 4th December 2017. The reported cause of death was myocardial infarction. An autopsy was not performed. It was unknown if the reporter considered the myocardial infarction to be related to INFLUSPLIT TETRA. Additional details were provided as follows: The patient was treated in intensive care unit. The patient received INFLUSPLIT TETRA on left deltoid. Spironolactone, Bisoprolol and ASA were applied permanently. This was one of the 9 cases, reported by the same reporter.


VAERS ID: 738261 (history)  
Form: Version 1.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-11-15
Onset:2017-12-14
   Days after vaccination:29
Submitted: 2018-02-16
   Days after onset:64
Entered: 2018-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-14
   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: Tilidin
Current Illness: Renal failure, grade IV; Dementia; Pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK025854

Write-up: This case was reported by a physician and described the occurrence of stroke in a 100-year-old female patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). Concurrent medical conditions included renal insufficiency (grade IV), dementia and pain. Concomitant products included Tilidin. On 15th November 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 14th December 2017, 29 days after receiving INFLUSPLIT TETRA, the patient experienced stroke (serious criteria death and GSK medically significant). On an unknown date, the outcome of the stroke was fatal. The patient died on 14th December 2017. The reported cause of death was stroke. An autopsy was not performed. The reporter considered the stroke to be unlikely related to INFLUSPLIT TETRA. Additional details were provided as follows: The patient received INFLUSPLIT TETRA on the left upper arm. No treatment was performed. Tilidin was applied permanently. This is one of the 9 linked cases reported by same reporter.


VAERS ID: 738342 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-10-13
Onset:2017-11-03
   Days after vaccination:21
Submitted: 2018-02-19
   Days after onset:108
Entered: 2018-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-11-03
   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; ASS 100; Simva 40
Current Illness: Coronary artery disease; Lipids; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK025848

Write-up: This case was reported by a physician and described the occurrence of unknown cause of death in a 73-year-old male patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). Concurrent medical conditions included coronary heart disease, lipids and hypertension. Concomitant products included ramipril, ASS 100 and Simva 40. On 13th October 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 3rd November 2017, 21 days after receiving INFLUSPLIT TETRA, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 3rd November 2017. The reported cause of death was unknown cause of death. An autopsy was not performed. The reporter considered the unknown cause of death to be unlike related to INFLUSPLIT TETRA. Additional information was provided as follows: The concomitant products Ramipril, ASS 100 and Simva 40 were applied permanently. The patient was administered INFLUSPLIT TETRA on left upper arm. No treatment was performed. The discrepant information was reported, the reporter ticked both boxes unlikely and unknown for causality assessment (causality was updated as per the other linked cases). This is one of the 10 linked cases, reported by the same reporter.


VAERS ID: 738345 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-11-15
Onset:2017-12-29
   Days after vaccination:44
Submitted: 2018-02-19
   Days after onset:52
Entered: 2018-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-29
   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: TILIDIN; Vitamin D
Current Illness: 2014, Hepatic cancer; pain; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK025816

Write-up: This case was reported by a physician and described the occurrence of unknown cause of death in a 87-year-old female patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). Concurrent medical conditions included liver carcinoma, pain and osteoporosis. Concomitant products included vitamin D and TILIDIN. On 15th November 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 29th December 2017, 44 days after receiving INFLUSPLIT TETRA, the patient experienced unknown cause of death (serious critieria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 29th December 2017. The reported cause of death was unknown cause of death. An autopsy was not performed. The reporter considered the unknown cause of death to be unlikely related to INFLUSPLIT TETRA. Additional details were provided as follows: The patient received INFLUSPLIT TETRA on left deltoid. No treatment was performed. TILIDIN and vitamin D were applied permanently. This is one of the 9 cases, reported by the same reporter.


VAERS ID: 738352 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-15
Onset:2017-12-29
   Days after vaccination:44
Submitted: 2018-02-19
   Days after onset:52
Entered: 2018-02-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-29
   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: LANITOP; TILIDIN
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK026160

Write-up: This case was reported by a physician and described the occurrence of stroke in a 95-year-old male patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). Concomitant products included LANITOP and TILIDIN. On 15th November 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 29th December 2017, 44 days after receiving INFLUSPLIT TETRA, the patient experienced stroke (serious criteria death and GSK medically significant). On an unknown date, the outcome of the stroke was fatal. The patient died on 29th December 2017. The reported cause of death was stroke. An autopsy was not performed. The reporter considered the stroke to be unlikely related to INFLUSPLIT TETRA. Additional information was provided as follows: The patient was administered INFLUSPLIT TETRA on left upper arm. No treatment was performed. The patient''s concomitant medications LANITOP Digoxin and TILIDIN were applied permanently. This is 1 of the 10 linked cases, reported by the same reporter.


VAERS ID: 738304 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-02-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-07
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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2018SA036795

Write-up: Initial unsolicited case received from a consumer (friend of patient''s cousin) on 08-Feb-2018. This case involves an around 38-year-old male patient who was vaccinated with dose of YELLOW FEVER VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on estimated by 01-Feb-2018 (also reported as around 7 days ago). The reporter informed that apparently patient had no health problem and it was informed that the patient did not fit any risk group of the vaccine. It was reported when the patient was a child, he experienced some unspecified reactions to unspecified vaccines. No information regarding concomitant medication or previous therapy was provided. On an unknown date, following the vaccination patient experienced two unspecified relapses, the first was lighter, the patient went to the hospital and was discharged, on the second relapse the patient went to the hospital and remained hospitalized under observation, experienced renal failure and maybe, some other unknown complications. At last, the patient evolved to death on 07-Feb-2018 at 10am. Laboratory test and corrective treatment were not reported It was not reported if autopsy was performed or not. List of documents held by sender: none. Sender''s Comments: This is a poorly documented, medically unconfirmed case reported after receipt of YF vaccine from unknown manufacturer which occurred in February 2018. A male patient (around 38 y.o.) experienced Renal failure with two subsequent relapses and other unspecified complications and died on 07-Feb-2018 (approximately 1 week after vaccination). Hospital discharge is not available, and cause of death is not reported. Additional information is needed about details of symptoms and their evolution, past medical history and health status at the time of vaccination, relevant investigation results ruling out a concurrent infection and other etiologies, autopsy report, vaccination details. Based upon the reported information the role of the vaccine could not be assessed. Reported Cause(s) of Death: some other unknown complications; first was light/ the second; renal failure.


VAERS ID: 738344 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-11-15
Onset:2017-12-10
   Days after vaccination:25
Submitted: 2018-02-19
   Days after onset:71
Entered: 2018-02-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS AFLBA221AA / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-14
   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: BALDRIAN
Current Illness: Asthma; 2015, Breast cancer, from 2015, the source document it remained unclear whether the breast cancer was still persistent; Sleep disorder; Hypertension
Preexisting Conditions: KADCYLA; Neoplasm, until end of 2016 the patient received Kadcyla for tumor therapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK025845

Write-up: This case was reported by a physician and described the occurrence of acute cardiac insufficiency in a 83-year-old female patient who received INFLUSPLIT TETRA (batch number AFLBA221AA, expiry date unknown). Previously administered products include Kadcyla (until end of 2016 the patient received Kadcyla for tumor therapy). Concurrent medical conditions included asthma, breast cancer (from 2015, the source document it remained unclear whether the breast cancer was still persistent), sleep disorder and hypertension. Concomitant products included valeriana officinalis (Baldrian). On 15th November 2017, the patient received the 1st dose of INFLUSPLIT TETRA (intramuscular). On 10th December 2017, 25 days after receiving INFLUSPLIT, the patient experienced acute cardiac insufficiency (serious criteria death and GSK medically significant). On 14th December 2017, the outcome of the acute cardiac insufficiency was fatal. The patient died on 14th December 2017. The reported cause of death was acute cardiac insufficiency. An autopsy was not performed. The reporter considered the acute cardiac insufficiency to be unlikely related to INFLUSPLIT. Additional information was provided as follows: The patient was administered INFLUSPLIT on left upper arm. No treatment was performed. The patient''s concomitant products included Baldrian and Rami which were applied permanently. This is 1 of the 10 linked cases, reported by the same reporter.


VAERS ID: 738370 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Dyspnoea, Endotracheal intubation, Hepatic failure, Jaundice, Pyrexia, Renal failure, Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (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: 2018-02-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2018SA037776

Write-up: Initial unsolicited report received from a nurse through a Social Media on 09-Feb-2018. This case involves an 84 years old male patient who was vaccinated with YELLOW FEVER VACCINE (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an un-specified date. Patient''s medical history and concomitant medications were not reported. On an unknown date second day after the vaccination patient experienced respiratory difficulty and weakness and patient was hospitalized. On an unknown date, third day after receiving the vaccine, the patient evolved to renal insufficient with low fever. On the second day of hospitalization and fourth day after receiving the vaccine, the patient was intubated with respiratory, insufficiency hepatic failure and renal failure. In 48 hours, the patient''s TGO level increased from 40 to 4300 (unit not provided) and on 08-Feb-2018, in the afternoon death happened, patient was completely icteric. The reporter informed that a patient that was healthy, active and non-sedentary, with medical authorization to perform the vaccine, with hypertensive disease controlled, renal and liver functions normal and without associated disease died after receiving the vaccine. It was reported by the reporter that the patient presented a super aggressive evolution and, according to his family, he was not sick for two years and, in the reporter''s opinion, analyzing the patient''s clinical condition and medical history, the possibility that the cause of this abrupt hepatic failure be another besides the vaccine was almost none. Other laboratory investigations and corrective treatment were not reported. It was not reported whether autopsy was performed or not. List of the documents held by sender: none. Sender''s Comments: This is a media case regarding an 84 years old man who received Yellow fever vaccine (manufacturer unknown) on an unspecified date and the second day post vaccination was hospitalized with complaints of respiratory difficulty and weakness. Later on, third and fourth day post-vaccination the patient developed renal insufficiency with low fever, respiratory insufficiency, hepatic failure and renal failure. In 48 hours, the patient''s TGO level increased from 40 to 4300 (unit not provided) and the patient died on 08 February 2018, in the afternoon, completely icteric. As reported, the patient had hypertensive disease controlled, was healthy and was not sick for two years. There is possibility that patient might have underlying undiagnosed conditions that presented post vaccination. Further information regarding concomitant vaccination, previous immunization history and tolerance, lab tests and autopsy results confirming the cause of death are needed to ascertain the cause of death. Based on available information the role of vaccine cannot be assessed. Reported Cause(s) of Death: hepatic failure; low fever; renal failure; respiratory insufficiency; Weakness.


VAERS ID: 738401 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningitis pneumococcal, Pneumococcal sepsis
SMQs:, Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZERINC2018067980

Write-up: This is a spontaneous report from a contactable consumer (the journalist). A 11-month-old, female patient of an unspecified ethnicity received PREVENAR 13 via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced pneumococcal sepsis and Pneumococcal meningitis who led to the patient death on Feb2018. It was not reported if an autopsy was performed. Information on the batch number has been requested. Reported Cause(s) of Death: Pneumococcal sepsis; Pneumococcal meningitis.


VAERS ID: 738443 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Hepatic failure
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2018SA039359

Write-up: Initial unsolicited case received from a health care professional social media on 09-Feb-2018. This case involves male patient (age not reported) who was vaccinated with dose of YELLOW FEVER VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history was not reported. Information about premedication, previous therapies and concomitant medications were not provided. On an unknown date, following the vaccination patient died. It was reported that reaction of the vaccine was questioned, but when analyzing the clinical picture and the clinical history of the patient was almost nil the cause of liver failure to be another. Laboratory test and corrective treatment were not reported It was not reported if autopsy was performed. List of documents held by sender: none. Sender''s Comments: This is a media case regarding a patient of unknown age who received Yellow fever vaccine (manufacturer unknown) on an unspecified date, developed liver failure on unspecified time after vaccination and died. Information about premedication, previous therapies and concomitant medications were not provided. There is possibility that patient might have underlying undiagnosed conditions that presented post vaccination. Further information regarding time to onset, symptoms and their evolution, past medical history and health status at the time of vaccination, relevant investigation results ruling out a concurrent infection and other etiologies, concomitant vaccination, previous immunization history and tolerance, lab tests and autopsy results confirming the cause of death are needed to assess the case. Based on available information the role of vaccine cannot be assessed. Reported Cause(s) of Death: liver failure.


VAERS ID: 738610 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Death, Measles, Morbillivirus test positive, Pneumonia
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GR0095075131802GRC009987

Write-up: This spontaneous report was received from a physician (Medical Lead Vaccines) regarding a 35 year old female patient, which was posted at the website of Agency. Information on medical history, current condition and concomitant medication was not reported. On an unknown date, the patient was vaccinated with an unspecified measles vaccine: either with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) or with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(manufacturer unknown) for prophylaxis (dosage and lot # unspecified). On an unknown date, the patient was diagnosed with pneumonia and acute respiratory distress syndrome (ARDS). On an unknown date, the patient underwent an unspecified laboratory test and was tested positive for measles. The outcome of the events was reported as fatal. The cause of death was reported as acute respiratory distress syndrome and pneumonia. It was unknown if an autopsy was performed. Causality assessment was not reported. Upon internal review, the events pneumonia, measles and acute respiratory distress syndrome were determined to be medically significant. Reported Cause(s) of Death: Acute Respiratory Distress Syndrome; Pneumonia.


VAERS ID: 738694 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2017-06-01
Submitted: 0000-00-00
Entered: 2018-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 - / SC

Administered by: Other       Purchased by: ?
Symptoms: Bacterial infection, Death, Pneumococcal infection, Serology positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2017-06-01
   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: Heart disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Serology test; Result Unstructured Data: Test Result: Serotype 35B
CDC Split Type: JPPFIZER INC2018072617

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 20-month-old female patient of an unspecified ethnicity received 3 doses of PREVENAR 13, (lot number unknown) subcutaneous, 1st and 2nd doses at single dose and 3rd dose at 0.5 ml, single on an unspecified date for immunisation. Medical history included ongoing heart disorder from an unknown date. The patient''s concomitant medications were not reported. The patient experienced invasive pneumococcal disease, serotype: 35b, on an unspecified date in Jun2017. The patient underwent lab tests and procedures which included serology test: serotype 35b on an unspecified date. The patient died on an unspecified date in Jun2017. It was not reported if an autopsy was performed. The reporting physician classified the seriousness of the event as serious (death and life-threatening), but did not assess the causality of the event to pneumococcal 13-val conj vac (dipht crm197 protein). The information on the batch number has been requested. Sender''s Comments: Reported event "invasive pneumococcal disease, serotype: 35b" (non- PREVENAR 13 containing serotype) more likely represents coincidental bacterial infection, which considered not related to PREVENAR 13. Reported Cause(s) of Death: invasive pneumococcal disease, serotype:35b.


VAERS ID: 738695 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-02-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Death, Hypokinesia, Social avoidant behaviour
SMQs:, Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (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: SESA2018SA045609

Write-up: Initial information regarding this unsolicited case downloaded from regulatory authority database without narrative (level 2A), was received on 15-Feb-2018 from Consumer or other Non-Health Professional via pharmaceutical company (GlaxoSmithKline) (Under reference number: SE-GLAXOSMITHKLINE-US2018GSK022450). The following narrative is based on the information retrieved from all other accessible data". This case involves a four-month-old patient (Gender was not reported), who was vaccinated with a dose of IPV oral drops, DTAP VACCINE SOLUTION FOR INJECTION, PNEUMOCOCCAL VACCINE, ROTAVIRUS VACCINE (Form oral drop) and HEPATITIS B VACCINE (Form: injection for solution} (batch number, expiry date, dose, dose series, route and site of administration was not reported for all vaccines) on an unknown date. Medical history and concomitant medication was not reported. On an unknown date, post vaccination the patient experienced withdrawn, moving less than before and no longer babbling or silent due to which patient died. Patient''s lab test and corrective treatment was not reported. It was unknown if autopsy was performed or not. There is causal relationship between Rotavirus vaccine, DTaP vaccine, Hepatitis B vaccine and events according to reporter and other pharmaceutical company. List of documents held by sender: none. Sender''s Comments: This is a poorly documented case concerning a 4 month old infant who died after vaccination with IPV, DTaP, PNEUMOCOCCUS, ROTAVIRUS and HEPATITIS vaccines. The date of vaccinations, the date of events, the date of death and the time interval between vaccination and the events is not reported. No information regarding medical history & tolerance to previous vaccinations was reported. Lab tests confirming the diagnosis were not reported. Autopsy confirmation is also not provided. Moreover, multiple vaccines were administered on unknown dates. Based upon reported information, the role of one vaccine cannot be assessed. Reported Cause(s) of Death: Movements reduced; Speech loss; Withdrawn.


VAERS ID: 739094 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-12-05
Onset:2017-12-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER N3C502V / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T65417 / UNK UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Sudden death, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-06
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2018077627

Write-up: This is an initial spontaneous report received from a contactable pharmacist via the National Health Products Safety Agency (ANSM) and downloaded from the Medicines Agency (MA) WEB FR-AFSSAPS-PA20180521. A 2-month-old male infant patient of an unspecified ethnicity received a dose of PREVENAR 13 (lot # T65417) at single dose, and HEXYON (lot # N3C502V), both by intramuscular route on 05Dec2017 for immunization. Neither relevant medical history nor concomitant medications were reported. On 06Dec2017, the patient experienced sudden infant death syndrome. No autopsy was performed. No FU attempts possible. Information about lot number already provided. No further information expected.; Reported Cause(s) of Death: Sudden death.


VAERS ID: 739211 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2017-11-02
Onset:2017-11-02
   Days after vaccination:0
Submitted: 2018-02-27
   Days after onset:117
Entered: 2018-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR N1J40 / UNK UN / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 160401 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R29022 / UNK UN / IM

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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KAY-CEE-L; Sodium phosphate; ABIDEC; SYTRON; SYNAGIS
Current Illness: Unknown
Preexisting Conditions: Premature baby, born at 25 weeks gestation; 09/06/2017, ROTARIX, Drug Indication: Immunisation, Drug Reaction: necrotising colitis, vaccinated on 06th September 2017
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2018031885

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of necrotizing enterocolitis in a 4-month-old female patient who received BEXSERO (batch number 160401, expiry date unknown). Co-suspect products included PREVENAR 13 (batch number R29022, expiry date unknown) and PEDIACEL (batch number N1J40, expiry date unknown). The patient''s past medical history included premature baby (born at 25 weeks gestation). Previously administered products included ROTARIX with an associated reaction of necrotising colitis (vaccinated on 06th September 2017). Concomitant products included KAY-CEE-L, sodium phosphate, SYNAGIS, ABIDEC and SYTRON. On 2nd November 2017, the patient received BEXSERO (intramuscular), PREVENAR 13 (intramuscular) and PEDIACEL (intramuscular). On 2nd November 2017, less than a day after receiving BEXSERO, the patient experienced necrotizing enterocolitis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the necrotizing enterocolitis was fatal. The reported cause of death was necrotizing enterocolitis. An autopsy was not performed. It was unknown if the reporter considered the necrotizing enterocolitis to be related to BEXSERO. Initial information was reported by a physician via regulatory authority on 21st February 2018.


VAERS ID: 739706 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-11-29
Onset:2018-01-05
   Days after vaccination:1863
Submitted: 0000-00-00
Entered: 2018-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0154AE / UNK UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Azotaemia, Blood culture positive, Cerebral infarction, Coma, Computerised tomogram head abnormal, Death, Haemodialysis, Mechanical ventilation, Oliguria, Pericarditis, Pneumococcal sepsis, Pneumonia, Renal failure, Septic encephalopathy, Septic shock, Tracheal dilation procedure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-02
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131802DEU011857

Write-up: This spontaneous report was received from a physician, via sales representative, referring to an 80-year-old female patient. Concurrent condition included recurrent atrial fibrillation. No information regarding the patient''s medical history and concomitant medications was reported. On 29-NOV-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, batch#H012264, lot#0154AE, expiration date: 19-DEC-2013 (also reported as March 2014), (exact dose and route of administration were not provided) for prophylaxis. On 05-JAN-2018, the patient was hospitalized due to vigilance reduction caused probably by septic encephalopathy. The patient was diagnosed with pneumococcal sepsis with bilateral pneumonia which led to septic shock with renal failure, uremia and oliguria. On an unknown date in January 2018, blood culture was made and presence of pneumococci were confirmed. On the same date, cerebral computed tomography (CCT) was made and showed multiple multifocal changes in brain and multi infarcts syndrome (cardio-embolic versus septic-embolic). The patient was also diagnosed with initial pericarditis. On unknown date, hemodialysis was performed, but renal function did not improve. From 05-JAN-2018 to 24-JAN-2018, the patient had long-term ventilation. On 23-JAN-2018, the patient had dilative tracheotomy. It was reported that the patient was the whole time in coma. On 02-FEB-2018, the patient died due to pneumococcal sepsis. It was not reported if autopsy was performed. The causality between the therapy with PNEUMOVAX 23 and the events was not reported. Upon internal review, the events of bilateral pneumonia, pneumococcal sepsis, septic encephalopathy, septic shock, renal failure, uremia, vigilance reduction, coma, pericarditis, cerebral infarction, long-term ventilation and dilative tracheotomy were considered medically significant.; Reported Cause(s) of Death: the patient died due to pneumococcal sepsis.


VAERS ID: 739899 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2014-08-28
Onset:2014-10-16
   Days after vaccination:49
Submitted: 2014-11-25
   Days after onset:40
Entered: 2018-03-06
   Days after submission:1197
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS J41451 / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drug ineffective, Pneumonia
SMQs:, Lack of efficacy/effect (narrow), 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: 2014-11-17
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 31 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014298751

Write-up: This is a spontaneous report from a contactable nurse from the Marketing Program. A 3-month-old female patient received first dose of PREVENAR 13, intramuscular, on 28Aug2014, at 0.5ml single. The patient''s medical history was not reported. Concomitant medications included PENTAXIM, intramuscular, on 28Aug2014, at single dose; Hepatitis B Vaccine, intramuscular, on 28Aug2014, at single dose; ROTARIX (Lot number J4145/1, Exp date Oct2014), oral, on 28Aug2014, at single dose. On 16Oct2014 the patient experienced bronchopneumonia and congenital rubella for which was hospitalized on 16Oct2014. She was diagnosed with bronchopneumonia. The patient received treatment due to the events. The patient''s hospitalization was prolonged as a result of the events. On 17Nov2014 the patient died due to the events. It was unknown if an autopsy was performed. Follow-up (19Nov2014, 21Nov2014): New information received from nurse from Marketing Program includes: reporters added, PREVENAR 13 details, concomitant added, event "congenital rubella" added, events "Drug ineffective" and "Bronchopneumonia" outcome updated, death details.


VAERS ID: 740185 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:1999-09-20
Onset:1999-09-01
Submitted: 0000-00-00
Entered: 2018-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Adenocarcinoma, Antibody test positive, Arrhythmia, Bradycardia, Condition aggravated, Coxsackie virus test positive, Death, Diarrhoea, Electromyogram abnormal, Endoscopy upper gastrointestinal tract abnormal, Endotracheal intubation, Gastrointestinal haemorrhage, Guillain-Barre syndrome, HIV test negative, Malaise, Mechanical ventilation, Neuropathy peripheral, Pneumonia, Sinus node dysfunction, Staphylococcal infection, Staphylococcus test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vasculitis (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 1999-12-12
   Days after onset: 102
Permanent Disability? Yes
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: Alcohol abuse; Arrhythmia; Bronchitis chronic; Chronic obstructive pulmonary disease; Common cold syndrome; Diabetes mellitus; Hepatic cirrhosis; Liver disorder; Prophylaxis; Sick sinus syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE00950751399120245

Write-up: Information has been received from a health care professional concerning a 66-year-old male patient. The patient''s concurrent condition included cirrhosis of the liver, alcohol abuse, hepatic disorder, diabetes mellitus (treated with insulin), chronic obstructive pulmonary disease, chronic bronchitis, arrhythmia and sick sinus syndrome. Concomitant therapy included influenza virus vaccine (unspecified). On 20-SEP-1999, the patient was vaccinated with PNEUMOVAX 23 (dose 1, 0.5 ml, intramuscular, frequency, lot# and expiration date were unknown) for prophylaxis. In 1999, he developed progressive ascending incomplete paralysis necessitating mechanical ventilation. The presumptive diagnosis was Guillain-Barre syndrome, however, the cerebrospinal fluid culture (CSF) examination did not reveal an increase in protein content. At the time of reporting, the patient had not yet recovered. The patient''s conditions were considered serious because of a life-threatening event, the admission to hospital and possibly permanent damage. Upon internal review, the event Guillain-Barre syndrome considered to be medically significant. Follow-up information received indicated that on 25-SEP-1999 the patient was hospitalized because he had suffered for several days from diarrhea and from a deterioration of his general condition. First a pneumonia of the right was diagnosed. In the further course the patient developed a progressive ascending paralysis without sensory deficit which led to intubation on 6-OCT-1999. That day a respiratory therapy was started. At that time the treating physicians assumed a Guillain-Barre syndrome (GBS) caused by the given vaccinations. A significant albumin increase was not found in several CSF''s. Repeated electromyography (EMG) and National Lawyers Guild (NLG) investigations indicated a polyradiculoneuropathy. No hints were given for multiple sclerosis, Borrelia, Epstein-Barr, varicella, Enteric cytopathic human orphan (ECHO), poliomyelitis or TBC. Human immunodeficiency virus (HIV) was negative. Investigations showed a slightly increased titer for Coxsackie virus and antibodies against Campylobacter. A gastroscopy at gastrointestinal bleeding showed a hardly differentiated adeno carcinoma in the esophagus and cardia area. Therefore, a paraneoplastic GBS was discussed as well. The patient developed repeated bronchopulmonary infections, finally with Methicillin-resistant Staphylococcus aureus (MRSA) positive staph. Aureus. For a short time the patient''s clinical condition had significantly improved but deteriorated dramatically in the end. The patient had to be supplied with oxygen again under permanent control. The patient died due to bradycardia arrhythmia with sick sinus syndrome on 12-DEC-1999 at 3:30 am. It was unknown if the autopsy was done. As agreed by the patient''s family, no resuscitation was performed. The reporter considered the event "Sinus arrhythmia", "neuropathy peripheral" and "respiratory disorder" to be life-threatening. Upon internal review, the event "pneumonia" considered to be medically significant. This is an amended report. The reporter indicated "yes" for alcohol abuse involving the patient. In addition the reaction onset date has been changed from 1999 to September 1999. Follow up information has been received on 04-MAR-2018, the patient concurrent condition also included common cold. The concomitant therapy was updated to INFLUVAC (previously reported as influenza virus vaccine (unspecified). It has been determined that case # 99120262 is a duplicate of case # 99120245 Therefore, case # 99120262 is being deleted from our files and the cases are consolidated into case 99120245. Sender''s Comments: MERCK 99120245: Mfr number; Reported Cause(s) of Death: Guillain-Barre Syndrome; susp. of polyradiculoneuropathy; Ascending Paralysis; bradycardia arrhythmia w/ sick sinus syndrome.


VAERS ID: 740683 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Depressed level of consciousness, Diarrhoea, Multiple organ dysfunction syndrome, Norovirus test positive, Polymerase chain reaction positive, Rotavirus infection, Rotavirus test positive, Viral infection, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (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), Pseudomembranous colitis (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), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Down''s syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131803JPN001088J

Write-up: Information has been received from a physician concerning a 1-year-old male infant with Down''s syndrome who was orally vaccinated for the 2nd time with rotavirus vaccine, live, oral, pentavalent oral solution (manufacturer unknown) for prophylaxis against gastroenteritis due to rotavirus (lot number, vaccination date and dose not reported). No concomitant medication was reported. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent for the first time. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent for the second time. On an unknown date, the patient was brought to a hospital because vomiting, diarrhoea and depressed level of consciousness were confirmed. On an unknown date, norovirus and a minute amount of rotavirus were detected in a real time polymerase chain reaction (RT-PCR) test of stool (infection mixed with rotavirus and norovirus was developed). On an unknown date, multi-organ failure occurred, and multimodal therapy was performed. On an unknown date (the seventh day of the treatment), the patient died. The causes of death were multi-organ failure and infection mixed with rotavirus and norovirus. Autopsy information was not obtained. Reporter''s comment: Not provided. The reporting physician considered multi-organ failure and infection mixed with rotavirus and norovirus to be serious due to death. Upon internal review, multi-organ failure and infection mixed with rotavirus and norovirus were determined to be medically significant. The reporting physician did not assess the relationship of multi-organ failure, infection mixed with rotavirus and norovirus to rotavirus vaccine, live, oral, pentavalent.; Reported Cause(s) of Death: Multi-organ failure; Infection mixed with rotavirus and norovirus.


VAERS ID: 740814 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2017-11-30
Onset:2017-12-01
   Days after vaccination:1
Submitted: 2018-03-14
   Days after onset:102
Entered: 2018-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER N3D201V / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH S58701 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB691AA / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-01
   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: ZA2018GSK041368

Write-up: This case was reported by a pharmacist via licensee and described the occurrence of death in a 3-month-old female patient who received ROTARIX liquid formulation (batch number AROLB691AA, expiry date 31st December 2018). Co-suspect products included HEXAXIM (batch number N3D201V, expiry date 28th February 2018) and PREVENAR (batch number S58701, expiry date 31st August 2019). On 30th November 2017, the patient received ROTARIX liquid formulation (oral), HEXAXIM and PREVENAR. On 1st December 2017, 1 days after receiving ROTARIX liquid formulation, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The patient died on 1st December 2017. The reported cause of death was death. It was unknown if the reporter considered the death to be related to ROTARIX liquid formulation. Additional details were provided as follows: The patient passed away a day later vaccination. The physician was doing an investigation and they suspect that the vaccines might have contributed to the passing of the baby but there was no proof of this as the investigation was on-going. The patient''s father did not come in to blame anyone or ask for anything, he just wanted to make pharmacy aware of what happened. The patient''s father even offered to put in contact with his physician and to get the preliminary results. This was the first time, the pharmacist received a query like this and was not sure what the protocol was for addressing an issue like this. The reporter did not commit to anything except that he would alert and pass on his information to you for you to possibly give him a call. It was unknown if the reporter considered the death to be related to HEXAXIM and PREVENAR as well. The reporter gave consent to be contacted.


VAERS ID: 740852 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-07-06
Onset:2017-07-23
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2018-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER M73964V / 2 - / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S15281 / 2 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Cardiac arrest, Cardiac failure, Death, Fibrosis, Lymphocytic infiltration, Myocarditis, Ventricular dysfunction
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2017-09-26
   Days after onset: 65
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2018101468

Write-up: This is a a spontaneous report downloaded from the Regulatory Authority [regulatory authority number DK-DKMA-ADR 24246687] received from a contactable physician. A 5-month-old female patient of an unspecified ethnicity received the 2nd dose of PREVENAR 13 (lot# S15281), intramuscular, on 06Jul2017, at single dose, for routine childhood immunization and the 2nd dose of HEXYON (lot# M73964V), intramuscular, on 06Jul2017, at 1 DF single, for routine childhood immunization. Relevant medical history and concomitant medications were not reported. Previously the patient received the 1st doses of PREVENAR 13 (lot # S15281) and HEXYON (lot # M7383) both on 28Apr2017 for immunisation. On 23Jul2017 the patient experienced manifest heart insufficiency; severe myocardial affect; reduced ventricular function; institio cordis, sudden cardiac arrest; severe lymphocytic infiltration in the myocardium; widespread fibrosis compatible with myocarditis; lymphocytic myocardial inflammation. The patient died on 26Sep2017 due to the reported events. All the events were serious as per hospitalization, life threatening and fatal. An autopsy was performed. No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: Institio cordis, sudden cardiac arrest; Severe lymphocytic infiltration in the myocardium; Widespread fibrosis compatible with myocarditis; Lymphocytic myocardial inflammation; Manifest heart insufficiency; severe myocardial affect; Reduced ventricular function.


VAERS ID: 740965 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Death, Interstitial lung disease, Loss of consciousness, Lymphadenopathy, Splenomegaly, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPSA2018SA068930

Write-up: Initial unsolicited report received from the literature on 07-Mar-2018. This case is linked to Related case: 2018-JPN-002047_CLUSTER (case id: 2018SA068932) (same reporter). Verbatim of the article Introduction: In forensic autopsy of infants, causal relationship between vaccination and a death may rarely be suspected. Although it is actually difficult to assess their direct causal relationship in forensic medicine, at least submission of physical and laboratory findings are requested in such cases. In the present study, infantile autopsy cases that died following vaccination were extracted from cases within past 4 years retrospectively and reviewed their details. Subjects: After being approved by Institutional Review Board as a retrospective study, 45 cases of sudden deaths in infants younger than 3 years were extracted from autopsy cases in Department of Forensic Medicine of University School of Medicine between 2013 and 2017, excluding definite deaths by external causes such as abuse and death by fire. Autopsy findings, information provided by the Police and mother''s handbooks for health were used as data. Results: Causal relationship with vaccination was suspected in autopsies of 2 cases (#1 and #2), both of which were deaths at 3 months of age immediately after receiving Hib, pneumococcal, hepatitis B and rotavirus vaccines following quadruple vaccine (DPT-IPV). Case #1 was found unconscious on the next day of the vaccination, and #2 had mild flulike symptoms and found dead while sleeping 3 days later. In both cases, autopsy findings indicated severe interstitial pneumonia with neck and peritoneal lymph node swelling and splenomegaly. Discussion: For situations immediately before the deaths, neither of the 2 cases had any prominent symptoms after the vaccination without visiting hospital, and both were found to have acute deterioration while sleeping. Their situations were similar to those of general SIDS cases. Effect of vaccination was suspected because it was pointed out by their parents. The autopsy findings had typical infectious picture with lymph node swelling and splenomegaly. Some other cases of acute death also had similar findings. There may be other cases of death where effect of vaccination should be suspected to lead to death. Concurrent vaccination such as Hib and pneumococcal vaccine caused accidental deaths in 2011, and the concurrent vaccination was discontinued but resumed later. The overall condition published at that time was similar to that in the present cases and causal relationships should therefore need to be considered carefully. This case involves a three-months-old patient (gender unknown) who was vaccinated with ACTHIB, PNEUMOCOCCAL VACCINE, HEPATITIS B VACCINE, ROTAVIRUS VACCINE, and DPT-IPV (batch number, expiration date, dose, dose in series, route and site of administration were not reported). The patient''s medical history and Concomitant medication was not reported. On an unknown next day following the vaccination patient was found unconscious and found dead while sleeping 3 days later. On an unknown day, the autopsy was performed and autopsy findings indicated severe interstitial pneumonia with neck and peritoneal lymph node swelling and splenomegaly. For situations immediately before the deaths, patient had no prominent symptoms after the vaccination without visiting hospital, and found to have acute deterioration while sleeping. Their situations were similar to those of general SIDS cases. Laboratory investigations and corrective treatment were not reported. The outcome of all the events was fatal. It was also reported that the patient had not any prominent symptoms after the vaccination without visiting hospital, and were found to have acute deterioration while sleeping. Effect of vaccination was suspected because it was pointed out by the parents. In forensic autopsy of infants, causal relationship between vaccination and a death may rarely be suspected. Although it is actually difficult to assess their direct causal relationship in forensic medicine, at least submission of physical and laboratory findings is requested in such cases. List of documents held by sender: none. Sender''s Comments: This case concerns a literature article in which a 3 month old infant died in sleep 3 days after vaccination (ACT-HIB and pneumococcal, hepatitis B, DPT-IPV and rotavirus vaccines). The infant was found unconscious. Autopsy results indicated severe interstitial pneumonia with lymph node swelling and splenomegaly which indicate towards an underlying infection. However, the age and clinical details correspond closely with the general Sudden Infant Death Syndrome (SIDS) cases. Further information regarding patient medical history, details regarding whether it was a premature birth or not, recent infectious history especially upper respiratory, allergic history, past vaccination history and its tolerance are needed to further assess the case. Moreover, multiple vaccinations preceded the event. Based upon the reported information, the role of the vaccines cannot be assessed individually. Reported Cause(s) of Death: severe interstitial pneumonia; splenomegaly; Sudden Death; Autopsy-determined Cause(s) of Death: severe interstitial pneumonia; splenomegaly; Sudden Death.


VAERS ID: 741214 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Hypotonia, Interstitial lung disease, Lymphadenopathy, Splenomegaly
SMQs:, Peripheral neuropathy (broad), Interstitial lung disease (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131803JPN000891J

Write-up: Initial information has been received from a physician concerning a 3-month-old infant who on an unspecified date was vaccinated with hepatitis B vaccine (product name unknown) (dose was not reported). Other suspect medications included diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine (SALK) (vaccinated date, dose unknown, indication: prophylaxis), pneumococcus vaccine (vaccinated date, dose unknown, indication: prophylaxis), live attenuated human rotavirus vaccine (vaccinated date, dose unknown, indication: prophylaxis) and adsorbed haemophilus type B vaccine (non-toxic) (vaccinated date, dose unknown, indication: prophylaxis). On an unspecified date, the patient was vaccinated with (non-toxic) Hib, pneumococcus vaccine, recombinant adsorbed hepatitis B vaccine (Yeast Origin), and live attenuated human rotavirus vaccine following diphtheria and DTaP-IPV. On an unspecified date, the patient died. The patient was found limply laying down on the following day of the vaccinations. The cause of death was not reported. Autopsy revealed severe interstitial pneumonia with dilated cervical/peritoneal lymph nodes and enlarged spleen. Reporter''s comment: The patient had no remarkable symptom and did not make hospital visits right before the death following the vaccination, and the condition suddenly changed while sleeping at home, which was corresponding to the typical condition of sudden infant death syndrome (SIDS). The influence by the vaccination was suspected as it was indicated by the patient''s parents. Upon internal review, death was considered to be serious due to other important medical event. The reporting physician felt that death was related to hepatitis B vaccine, and considered diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine, pneumococcus vaccine, live attenuated human rotavirus vaccine and adsorbed haemophilus type B vaccine as suspect drugs. This is one of the several reports received from the same source. Sender''s Comments: JP-MSD-1803JPN001079J: Reported Cause(s) of Death: Death.


VAERS ID: 741215 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Interstitial lung disease, Nasopharyngitis, Splenomegaly
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131803JPN001079J

Write-up: It was reported in a meeting abstract. Initial information has been received from a physician concerning a 3-month-old infant who on an unspecified date was vaccinated with hepatitis b vaccine (product name unknown) (dose not reported). Other suspect medications included diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine (SALK) (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND. INACTIVATED POLIOVIRUS VACCINE (SALK)) (vaccinated date, dose unknown, indication: prophylaxis) , pneumococcus vaccine (PNEUMOCOCCUS VACCINE) (vaccinated date, dose unknown, indication: prophylaxis), live attenuated human rotavirus vaccine (LIVE ATTENUATED HUMAN ROTAVIRUS VACCINE) (vaccinated date, dose unknown, indication: prophylaxis) and adsorbed haemophilus type b vaccine (non-toxic) (ADSORBED HAEMOPHILUS TYPE B VACCINE (NON-TOXIC)) (vaccinated date, dose unknown, indication: prophylaxis). On an unspecified date, the patient was vaccinated with adsorbed haemophilus type b vaccine (non-toxic) (Hib), pneumococcus vaccine, recombinant adsorbed hepatitis B vaccine (Yeast Origin), and live attenuated human rotavirus vaccine following diphtheria and tetanus toxoids and acellular pertussis adsorbed and. inactivated poliovirus vaccine 4-component vaccine (DPT-IPV). On an unspecified date, the patient found dead while sleeping 3 days after mild symptoms of common cold were noted. The cause of death was not reported. Autopsy revealed severe interstitial pneumonia with dilated cervical/peritoneal lymph nodes and enlarged spleen. Reporter''s comment: The patient had no remarkable symptom and did not make hospital visits right before the death following the vaccination, and the condition suddenly changed while sleeping at home, which was corresponding to the typical condition of sudden infant death syndrome (SIDS). The influence by the vaccination was suspected as it was indicated by the patient''s parents. Upon internal review, death was considered to be serious due to other important medical event. The reporting physician felt that death was related to hepatitis b vaccine, and considered diphtheria and tetanus toxoids and acellular pertussis adsorbed and. inactivated poliovirus vaccine, pneumococcus vaccine, live attenuated human rotavirus vaccine and adsorbed haemophilus type b vaccine as suspect drugs. This is one of the several reports received from the same source.; Sender''s Comments: JP-MSD-1803JPN000891J:; Reported Cause(s) of Death: Death.


VAERS ID: 741443 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-03-20
Entered: 2018-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK045832

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


VAERS ID: 741629 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2018-02-28
Onset:2018-03-01
   Days after vaccination:1
Submitted: 2018-03-21
   Days after onset:19
Entered: 2018-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Aspiration bronchial, Child abuse, Death
SMQs:, Hostility/aggression (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-03-01
   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: CO2018GSK045817

Write-up: This case was reported by a nurse via patient support programs and described the occurrence of child abuse in a 2-month-old female patient who received SYNFLORIX. Co-suspect products included ROTARIX, Poliomyelitis vaccine inactivated and DTP-HBV/HIB. On 28th February 2018, the patient received the 1st dose of SYNFLORIX .5 ml, the 1st dose of ROTARIX (oral), the 1st dose of Poliomyelitis vaccine inactivated and the 1st dose of DTP-HBV/HIB. On 1st March 2018, 1 days after receiving SYNFLORIX, ROTARIX, Poliomyelitis vaccine inactivated and DTP-HBV/HIB, the patient experienced child abuse (serious criteria death) and aspiration bronchial (serious criteria death). On 1st March 2018, the outcome of the child abuse and aspiration bronchial were fatal. The patient died on 1st March 2018. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the child abuse and aspiration bronchial to be related to SYNFLORIX, ROTARIX, Poliomyelitis vaccine inactivated and DTP-HBV/HIB. Additional details were reported as follows: This case was reported via patient support program but was not derived from organized data collection schemes. The patient received 1st dose of the vaccines as stipulated in the vaccine schedule. Currently the cause of death was being investigated for presumed child abuse or bronchial aspiration. Lot numbers were not reported. There was no additional information reported.


VAERS ID: 741832 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-03-15
Onset:2018-03-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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: 2018-03-19
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PH0095075131803PHL009601

Write-up: This spontaneous report has been received from a nurse coordinator, concerning a female patient of unknown age. The patient''s medical history, concurrent conditions and concomiotantn medications were not provided. On 15-MAR-2018 (Thrusday), the patient was vaccinated with GARDASIL for prophylaxis (dose, frequency, route, lot number and expiration date were not provided. On 16-MAR-2018 (Friday), the patient experienced vomiting, fever and was hospitalized. On 19-MAR-2018 (Monday), the patient died for unknown cause of death. It was unknown if autopsy was performed. The outcome of vomiting and fever was unknown. The causal relationship between the adverse events and GARDASIL was not assessed.; Reported Cause(s) of Death: patient died.


VAERS ID: 741946 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Death, Fatigue, Headache, Stress
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Human papilloma virus immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA0095075131803CAN009699

Write-up: This spontaneous report as received from a consumer (Mother of patient) through Social media via company representative refers to a 17-year-old female patient. Information on patient''s pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL (strength, dose, lot number and expiry date not reported) to prevent HPV infection. On an unknown date, she received the second shot of GARDASIL. On an unknown date in 2008, after the second shot, she was complaining of headaches, a pain in the lower left back of her head, and felt really tired, her joints ached. They took her back to the family doctor who told them that it was just stress and suggested TYLENOL. On an unknown date in 2008, 40 hours after receiving the third dose of GARDASIL, the patient died. The cause of death was unknown. It was unknown if autopsy was performed. The outcome of the headache, stress, arthralgia and fatigue was not reported. The reporter considered the events to be related to GARDASIL.


VAERS ID: 742170 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-02-19
Onset:2018-02-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2018-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VNS1R13B / 1 RA / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER N010906 / 1 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-26
   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: Common cold; Routine childhood immunization
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NL0095075131803NLD008999

Write-up: Information has been downloaded from regulatory authority (NL-LRB-00273847 and NL-LRB-00274514). This spontaneous report has been received from a consumer concerning a 14 month old male patient. The patient''s concurrent conditions included common cold which started on an unknown date in December 2017. The patient''s medical history, drug allergies and concomitant therapies were not reported. On 19-FEB-2018, the patient was vaccinated with the first dose of M-M-RVAXPRO 0.5ml, with lot number N010906 and expiration date on 31-MAR-2019, 1 Dosage Form administered in the left upper arm for routine childhood immunization (route of administration was not provided). Other suspect therapies included the first dose of NEISVAC-C 20microgram/ml, with lot number VNS1R13B, 1 Dosage Form administered in the right upper arm for routine childhood immunization (route of administration was not provided). On 26-FEB-2018, 7 days after vaccination the patient was found dead in bed. It were unknown the cause of death and if an autopsy was performed. The causal relationship between the suspect therapies and the events was reported as possible. Reported Cause(s) of Death: cause of death unknown, results investigation of death cause follow.


VAERS ID: 742221 (history)  
Form: Version 2.0  
Age: 1.42  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningitis pneumococcal, Streptococcus test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Result Unstructured Data: Test Result: streptococcal pneumoniae meningitis; Test Name: CSF culture; Result Unstructured Data: Test Result: streptococcal pneumoniae meningitis
CDC Split Type: SAPFIZERINC2018121385

Write-up: This is a spontaneous report from a contactable physician. A 15-month-old patient of an unspecified ethnicity and gender received PREVNAR13 on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient missed his booster dose which should be on his 12th month. On an unspecified date the patient experienced streptococcal pneumoniae meningitis. Blood and CSF cultures confirmed streptococcal pneumoniae meningitis. Patient was admitted to the hospital for empirical therapy and investigation; on an unknown date patient died due to complications of the infection. It was not reported if an autopsy was performed. Information on the batch number has been requested. Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Reported Cause(s) of Death: streptococcal pneumoniae meningitis; streptococcal pneumoniae meningitis.


VAERS ID: 742608 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2018-03-01
Submitted: 0000-00-00
Entered: 2018-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningitis pneumococcal
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-03-27
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2018129614

Write-up: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 13 month-old female patient of an unspecified race and ethnicity received two single doses of PREVENAR 13 on unspecified dates for immunisation. It was unknown if the patient had received the booster (3rd) single dose at 12 months. The patient''s medical history and concomitant medications were not reported. The patient experienced meningitis pneumococcal in Mar2018. Pneumococcus serotype was unknown. The patient was hospitalized for meningitis pneumococcal on 25Mar2018 and died on 27Mar2018. It was not reported if an autopsy was performed. The reported cause of death was meningitis pneumococcal. The information on batch number has been requested.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results are needed for full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Meningitis pneumococcal; Meningitis pneumococcal.


VAERS ID: 743093 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-03-26
Onset:2018-03-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-03-29
   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: JANUVIA; UBRETID; AMLODIPINE; BROTIZOLAM; FLOMOX
Current Illness: Diabetes mellitus; Dysuria; Hypertension; Insomnia; Schizophrenia; Urinary tract infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131803JPN003488J

Write-up: Information has been received from a pharmacist concerning a 75 year-old female patient with schizophrenia who on 26-MAR-2018 was subcutaneously vaccinated with PNEUMOVAX NP injection, 0.5 ml for pneumonia prophylaxis (lot number not reported). The patient had no medical history. Concomitant medications included sitagliptin phosphate (JANUVIA TABLETS 50MG), distigmine bromide (UBRETID), amlodipine besilate (AMLODIPINE), brotizolam (BROTIZOLAM) and cefcapene pivoxil hydrochloride hydrate (FLOMOX). On 29-MAR-2018, 11:00 AM after joining occupational therapy in hospital, the patient developed cardio-respiratory arrest in patients'' room. Afterwards, death was confirmed. The cause of death was cardio-respiratory arrest. Autopsy information was not obtained. Reporter''s comment: Sudden death. Though it was considered that there was no causal relationship with drug including pneumococcal vaccine, polyvalent (23-valent), I reported because of death. The reporting pharmacist assessed the cardio-respiratory arrest as serious due to death. Upon internal review, cardio-respiratory arrest was determined to be medically significant. The reporting pharmacist felt that cardio-respiratory arrest was not related to pneumococcal vaccine, polyvalent (23-valent). Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported event of cardio respiratory arrest considered unlikely related to PNEUMOVAX vaccine. The evidence is not sufficient to suggest a relationship between the vaccine and the reported serious adverse event. Cardiopulmonary arrest (event without regard to suspected therapy) constitutes a more plausible alternative explanation for the event. Company Comment- No changes to the product safety information are warranted at this time. Merck and Co., Inc., continues to monitor the safety profile of the product.; Reported Cause(s) of Death: Cardio-respiratory arrest.


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

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Contusion, Death, Drug interaction, Haemoptysis, International normalised ratio decreased, Platelet count decreased, Pyrexia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROXYCHLOROQUINE; HYDROCHLOROTHIAZIDE; MONTELUKAST; LORAZEPAM; CELECOXIB; ASA; warfarin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: international normalized ratio; Result Unstructured Data: 8
CDC Split Type: ITSA2018SA095111

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Warfarin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA095112

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


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

Administered by: Other       Purchased by: ?
Symptoms: Albumin CSF increased, Arrhythmia, CD4/CD8 ratio, CSF immunoglobulin increased, CSF oligoclonal band, CSF protein increased, Cardiac failure, Cardiopulmonary failure, Chromaturia, Death, Guillain-Barre syndrome, Hypoaesthesia, Hypotonia, Mobility decreased, Muscular weakness, Nephropathy, Pain in extremity, Paralysis, Pneumonia, Renal impairment, Rhabdomyolysis, Sepsis, Supraventricular tachycardia
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Cardiac failure (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TAMSULOSIN; HYDROCHLOROTHIAZIDE; CLONIDINE; GEMFIBROZIL; ACETYLSALICYLIC ACID; TORSEMIDE; QUINAPRIL; VALSARTAN; PREGABALIN; INSULIN; PARICALCITOL; CALCIUM; simvastatin
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic nephropathy; End stage renal disease (DUE TO GBS); Guillain Barre syndrome; Stroke; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: CD4/CD8 ratio; Result Unstructured Data: NORMAL; Test Name: CSF oligoclonal band; Result Unstructured Data: UNK; Comments: ISOELECTRIC FOCUSING; Test Name: Protein total; Test Result: 133 mg/dl; Test Name: IgG; Test Result: 11.20 mg/dl; Test Name: albumin; Test Result: 77.7 mg/dl
CDC Split Type: ITSA2018SA095116

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


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

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Coagulopathy, Death, Drug interaction, International normalised ratio increased
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage laboratory terms (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Warfarin
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: DVT (DEEP VEIN THROMBOSIS); Non-Hodgkin''s lymphoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA095117

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


VAERS ID: 743301 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-08-10
Onset:2017-08-15
   Days after vaccination:5
Submitted: 2018-04-06
   Days after onset:234
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Unknown
Symptoms: Autopsy, Death, Necrotising enterocolitis neonatal, Neonatal hypoxia
SMQs:, Acute central respiratory depression (broad), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-15
   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: Paracetamol; Domperidone; Morphine sulfate; Phenobarbital; Caffeine Citrate; Omeprazole; Metronidazole; Fluconazole; VISCOTEARS; Flucloxacillin; Nystatin; Acyclovir; Vancomycin; CERATONIA; Furosemide; Cyclopentolate; Gentamicin; Hyoscine hy
Current Illness: Gastrooesophageal reflux disease, Severe; Intensive care; Dysphagia, inability to swallow own saliva; Cytogenetic abnormality, Chromosome 3 duplication
Preexisting Conditions: Premature baby, Born at 29 weeks gestation, birth weight 1490g, poor condition at birth; Neonatal hypoxia, Perinatal hypoxia ischemia; Breech delivery, Obstructed breech delivery. (mother delivery related); Apgar score, Apgar''s 0,0,0 & 3 at 1, 5, 10 & 20 minutes of age
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2018056559

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of necrotizing enterocolitis neonatal in a 65-day-old male patient who received ROTARIX. The patient''s past medical history included neonatal hypoxia (Perinatal hypoxia ischemia), breech delivery (mother delivery related) and Apgar''s 0,0,0 & 3 at 1,5,10 and 20 minutes of age). Previously administered products included Premature baby (Born at 29 weeks gestation, birth weight 1490g, poor condition at birth). Concurrent medical conditions included gastroesophageal reflux (Severe), intensive care, unable to swallow (Inability to swallow own saliva) and Chromosome 3 duplication). Concomitant products included BEXSERO, INFANRIX-IPV + Hib), Morphine Sulfate, phenobarbital, omeprazole, metronidazole, fluconazole, Flucloxacillin, nystatin, Aciclovir, nutritional supplement, Gentamicin, Furosemide, Glycopyrronium, Phenylephrine, clotrimazole, PREVENAR 13, CISCOTEARS, Vancomycin, ceratonia, Cyclopentolate, meropenem, (NOS) Infant GAVISCON), ABIDEC. On August 2017, the patient received ROTARIX (oral) 1.4 ml. On 11 August 2017, 1 days after receiving ROTARIX, the patient experienced neonatal oxygen desaturation (serious criteria GSK medically significant and other: serious per reporter). On 15th August 2017, 5 days after receiving ROTARIX, the patient experienced necrotizing enterocolitis neonatal (serious criteria death, GSK medically significant and other: serious per reporter). On 15th August 2017, the outcome of the necrotizing enterocolitis neonatal was fatal. On an unknown date, the outcome of the neonatal oxygen desaturation was unknown. The patient died on 15th August 2017. The reported cause of death was necrotizing enterocolitis neonatal. An autopsy was performed. The autopsy determined cause of death was necrotizing enterocolitis neonatal. It was unknown if the reporter considered the necrotizing enterocolitis neonatal and neonatal oxygen desaturation to be related to ROTARIX. Additional information: The age at vaccination was not reported. ABIDEC concomitant product was reported for unknown indication. Product brand name Certonia was reported as Carobel. Initial information was received from a physician via regulatory authority no 30th March 2018: Necrotising enterocolitis neonatal and neonatal oxygen desaturation.


VAERS ID: 743877 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-11-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK GM / IM

Administered by: Other       Purchased by: ?
Symptoms: Death, Dysphagia, Hydrophobia, Mydriasis, Product administered at inappropriate site, Pupil fixed, Rabies, Vaccination failure, Wound treatment
SMQs:, Lack of efficacy/effect (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: INSA2018SA098119

Write-up: Initial unsolicited report received from literature on 30-Mar-2018. Abstract: A 48-year-old male was bitten by a dog on the forehead and on the RIGHT side of left eyebrow on November 26, 2017, at 2 pm. The patient was immediately rushed to a nearby private hospital where a doctor gave him immediate wound wash with soap and water and prescribed five doses of rabies vaccine intramuscularly (IM). Since the patient weight was 60 kg, he was also prescribed 2400 IU of equine rabies immunoglobulin (ERIG), but as eRIG was not available, it was not administered. All the four doses of rabies vaccine were given IM in gluteus muscle. On December 17, 2017, the patient was brought to the Regional Hospital with the symptoms of difficulty in swallowing water for 2 days. He was given injection diazepam and referred to Medical College, where he died of suspected rabies on December 19, 2017. The explicit consent to publish this report and picture was taken from the relatives of the patient, so that others have a lesson from this case report. This case involves a 48-year-old male patient who was vaccinated with four doses of Rabies vaccine (batch number, expiry date, route and site of administration were not reported) intramuscularly in gluteus muscle in the buttocks on unknown dates. The patient was bitten by a dog on the forehead on the right side of left eyebrow on 26-Nov-2017. The patient was immediately rushed to a nearby private hospital where a doctor gave him immediate wound wash with soap and water. Concomitant medications were not reported. On an unspecified date, post vaccination, the patient had difficulty in swallowing water for 2 days and went to one hospital, and also had a fixed gaze with dilated pupil in between fits of hydrophobia. Patient was referred to another hospital and the patient died due to suspected rabies on 19-Dec-2017. It was a case of actual medication error due to vaccine administered at inappropriate site. It was also a case of vaccination failure. Lab investigations were not reported. The patient was given injection of Diazepam as corrective treatment. It was unknown if an autopsy was performed or not. It was reported that the patient was given rabies vaccine in gluteus muscle instead of deltoid muscle and that proved to be ineffective and lead to development of hydrophobia and death due to rabies. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder''s compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Sender''s Comments: A 48-y.o. male bitten by a dog on face, died of suspected rabies 23 days after exposure despite having received rabies vaccine (unknown manufacturer, name or lot number not reported) for post exposure prophylaxis. Appropriate wound care was done immediately and rabies vaccination was started without delay, however the vaccine was administered in gluteus muscle and no Rabies immunoglobulins were given. Lab test confirming the diagnosis or autopsy results confirming cause of death were not provided, however the symptoms and their evolution were compatible with clinical rabies. Based upon reported information the PEP failure is likely due to lack of RIG administration; in addition inappropriate site of vaccine administration could lead to lower or delayed immune response to the vaccine. Reported Cause(s) of Death: fixed gaze; Hydrophobia; suspected rabies; Vaccine Failure leading to death/Failure of Post exposure Prophylaxis; given rabies vaccine in gluteus muscle and that proved to be ineffective and lead to development of hydrophobia and death due to rabies.


VAERS ID: 743911 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2018-03-13
Submitted: 2018-04-11
   Days after onset:29
Entered: 2018-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B270BE / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Foetal death
SMQs:, 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: Paracetamol
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ES2018056279

Write-up: This prospective pregnancy case was reported by a physician via regulatory authority and described the occurrence of death fetal in a patient exposed to BOOSTRIX (batch number AC37B270BE, expiry date unknown) in utero. The mother received the product for prophylaxis. Co-suspect product exposures included paracetamol unknown. On an unknown date, the 26-year-old mother received BOOSTRIX (intramuscular). On 28th February 2018, the mother started paracetamol (unknown) at an unknown dose and frequency. 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 death fetal (serious criteria death, GSK medically significant and other). On an unknown date, the patient experienced maternal vaccine exposure. On an unknown date, the outcome of the death fetal was fatal and the outcome of the maternal vaccine exposure was unknown. The reported cause of death was fetal death. It was unknown if the reporter considered the death fetal to be related to BOOSTRIX and paracetamol. Additional information: The age at vaccination was not reported. The batch number of BOOSTRIX-polio was reported as AC37B270BE. However, upon review of sales datasheet for batch number AC37B270BE, the BOOSTRIX-polio was corrected to BOOSTRIX. The TTO of paracetamol for the event was reported as 14 days. However, as per product and event start date the TTO was for paracetamol was captured as 13 days. Initial information was reported by a physician via regulatory authority on 3rd April 2018. Death fetal and maternal vaccine exposure.


VAERS ID: 743914 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-04-11
Entered: 2018-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA2018GSK060504

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of death NOS in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced death NOS (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death NOS was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death NOS to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter''s sister died from the vaccine. No possibility of follow up was reported.


VAERS ID: 744504 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-12-14
Onset:2017-12-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC850A / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T52809 / 2 UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Clonus, Death, Skin warm
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 meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-14
   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: propranolol
Current Illness: Down''s syndrome; Heart disease congenital
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZERINC2018151391

Write-up: This is a spontaneous report from a contactable physician downloaded from the Agency (IT-MINISAL02-462108), then received from Italian Health Authority. A 6-month-old male patient of an unspecified ethnicity received the second dose of PREVENAR 13 (lot number T52809, expiry date 31Aug2019) on 14Dec2017 at 09:12 a.m. and the second dose of INFANRIX HEXA (lot number A21CC850A, expiry date 28Feb2019) on 14Dec2017 at 09:10 a.m., both intramuscular at 0.5 ml single on 14Dec2017 for immunization. Medical history included Down''s syndrome and tetralogy of Fallot with atrial septal defect on 12Jun2017 and ongoing. Concomitant medication included oral propranolol (manufacturer unknown) at 10 mg, 1x/day from 20Jul2017 and ongoing for tetralogy of Fallot with atrial septal defect. On 14Dec2017, 10 hours after the vaccination the patient appeared hot when touched, he developed arrest cardiac, clonic spasm. The patient died on 14Dec2017 due to the events. It was not reported if an autopsy was performed. Reported Cause(s) of Death: Arrest cardiac; Clonic spasm; the patient appeared hot when touched.


VAERS ID: 745198 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2017-10-07
Submitted: 2018-04-20
   Days after onset:195
Entered: 2018-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hepatic failure, Hepatocellular injury, Metabolic acidosis, Nervous system disorder
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-09
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2018065408

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of liver failure in a 4-month-old male patient who received INFANRIX. Co-suspect products included PREVENAR 13. On an unknown date, the patient received INFANRIX (unknown) 1 dosage form(s) and PREVENAR 13 (unknown) 1 dosage form(s). On 7th October 2017, less than a year after receiving INFANRIX, the patient experienced metabolic acidosis (serious criteria death). On 8th October 2017, the patient experienced liver failure (serious criteria death and GSK medically significant), neurological disorder NOS (serious criteria death) and hepatic cytolysis (serious criteria death and GSK medically significant). On 9th October 2017, the outcome of the liver failure, neurological disorder NOS, hepatic cytolysis and metabolic acidosis were fatal. The patient died on 9th October 2017. The reported cause of death was metabolic acidosis, failure liver, neurological disorder NOS and hepatic cytolysis. An autopsy was not performed. It was unknown if the reporter considered liver failure, neurological disorder NOS, hepatic cytolysis and metabolic acidosis to be related to INFANRIX. Additional details: The age at vaccination was not reported. However age at event was reported as 4 months. Initial information was received from a physician via regulatory authority on 16th April 2018: Failure liver, neurological disorder NOS, hepatic cytolysis and acidosis metabolic.


VAERS ID: 745616 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-04-24
Entered: 2018-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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: 0000-00-00
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: IL2018GSK070351

Write-up: This case was reported in a literature article and described the occurrence of arrhythmia in a 20-year-old patient who received HPV vaccine. On an unknown date, the patient received HPV vaccine at an unknown dose. On an unknown date, unknown after receiving HPV vaccine, the patient experienced arrhythmia (serious criteria death and GSK medically significant) and cardiac arrest (serious criteria death and GSK medically significant). On an unknown date, the outcome of the arrhythmia and cardiac arrest were fatal. The reported cause of death was arrhythmia and cardiac arrest. The reporter considered the arrhythmia and cardiac arrest to be related to HPV vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of fatal arrhythmia and cardiac arrest in a 20-year-old of unspecified gender who was vaccinated with unspecified HPV vaccine (manufacturer unknown). No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified HPV vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period following the vaccination, the patient developed arrhythmia and cardiac arrest that led to death. It was unknown if an autopsy was performed. Treatment was unknown. The authors stated "First launched in 2006, the aim was to substantially reduce the burden associated with HPV-related neoplasms. And indeed, the vaccine has been found to be effective, providing a long-lasting protection against HPV infection and premalignant lesions. There appears to be a fine balance between the efficacy of vaccines and their potential toxicity. This is because the same mechanisms that drive the immune-stimulatory effect of vaccines have the capacity to provoke a variety of autoimmune adverse reactions. In the current literature, there are numerous cases substantiating the link between adverse auto-immune reactions and HPV vaccines".


VAERS ID: 745914 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LBPFIZER INC2018165568

Write-up: This is a spontaneous report from a contactable physician. A female patient of an unspecified age and ethnicity received PREVENAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history and concomitant medications were not reported. This woman died 10 days after receiving pneumococcal 13-val conj vac (dipht crm197 protein). The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the batch number has been requested. Sender''s Comments: This report is lacking information critical for an independent medical assessment (i.e. medical history, concomitant medications and patient demographics and autopsy results). Per company guidance, "death cause unknown" is processed as "related" until sufficient information becomes available to confirm an unrelated cause of death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 746147 (history)  
Form: Version 1.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2017-12-15
Submitted: 2018-04-27
   Days after onset:132
Entered: 2018-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 GM / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Dysphagia, Gaze palsy, Hydrophobia, Mydriasis, Product administered at inappropriate site, Rabies, Staring
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ocular motility disorders (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-12-19
   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: Unknown
Preexisting Conditions: 11/26/2017, Anima bite, at 2 pm bitten by a dog on the forehead on the right side of left eyebrow
Allergies:
Diagnostic Lab Data:
CDC Split Type: IN2018GSK073826

Write-up: This case was reported in a literature article and described the occurrence of rabies in a 48-year-old male patient who received Rabies Vaccine. Concurrent medical conditions included dog bite (at 2 pm bitten by a dog on the forehead on the right side of left eyebrow). Concomitant products included Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. On an unknown date, the patient received the 4th dose of Rabies Vaccine (intramuscular). On 15th December 2017, less than a month after receiving Rabies Vaccine, the patient experienced rabies (serious criteria death, hospitalization and GSK medically significant), hydrophobia (serious criteria hospitalization) and pupils dilated (serious criteria hospitalization). In December 2017, the patient experienced staring (serious criteria hospitalization). On an unknown date, the patient experienced vaccine administered at inappropriate site. The patient was treated with diazepam. On 19th December 2017, the outcome of the rabies was fatal. On an unknown date, the outcome of the hydrophobia, staring, pupils dilated and vaccine administered at inappropriate site were unknown. The patient died on 19th December 2017. The reported cause of death was rabies. The reporter considered the rabies, hydrophobia, staring and pupils dilated to be related to Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of suspected rabies in a 48-years-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown). On 26 November 2017, at 2 pm, the patient was bitten by a dog on the forehead on the right side of left eyebrow. The patient was immediately rushed to a nearby private hospital where a doctor gave him immediate wound wash with soap and water and prescribed five doses of rabies vaccine intramuscularly (IM). Since the patient weight was 60 kg, he was also prescribed 2400 IU of equine rabies immunoglobulin (eRIG). No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received 4 doses of unspecified rabies vaccine (batch number not provided) intramuscularly in gluteus muscle in the buttocks. Age of vaccination was not provided. On 17 December 2017, an unknown period after vaccination, the patient was brought to the Regional Hospital with the symptoms of difficulty in swallowing water (Hydrophobia) for 2 days. The patient had symptoms of hydrophobia having a fixed gaze with dilated pupil in-between fits of hydrophobia. He was given the injection of diazepam and referred to another government hospital. On 19 December 2017, the patient died of suspected rabies. It was unknown if ten autopsy was performed. This case has been considered serious due to death/hospitalisation. The author stated, "our patient was given rabies vaccine in gluteus muscle and that proved to be ineffective and lead to development of hydrophobia and death due to rabies. This case report again highlights the peril of giving rabies vaccine IM in gluteus muscle that may lead to rabies and should be avoided."


VAERS ID: 746689 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2009-08-01
Onset:2009-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-05-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / SYR

Administered by: Other       Purchased by: ?
Symptoms: Death, Headache, Myalgia, Paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-05-20
   Days after onset: 1023
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: DESA2018SA120809

Write-up: Initial information regarding this unsolicited case downloaded from Regulatory Authority database without narrative (level 2A), was received on 25-Apr-2018 from consumer via health authority (reference number: DE-CADRPEI-2018022222). The following narrative is based on the information retrieved from all other accessible data. This case involves a 56-year-old female patient, who was vaccinated with a first injection dose of TETANUS TOXOID (Batch number, expiry date, dose, dose series, route and site of administration were not reported) via Intravenous (not otherwise specified) route on an unknown date of Aug-2009. The patient''s medical history and concomitant medication was not reported. On an unknown date of Aug-2009, post vaccination, the patient developed Paralysis, muscle pain and headache. Patient''s lab test and corrective treatment were not reported. On 20-May-2012, patient died due to events. It was unknown if autopsy was performed. Sender''s Comments - As long as the validation is not available this case need to seen as reported but not medically validated. List of documents held by sender: none. Sender''s Comments: The patient experienced paralysis, headache and muscle pain post vaccination with Tetanus Toxoid (unknown manufacturer). Time to onset was compatible. The patient died of unverified cause approximately three years post onset of events. Patients medical history was not known. Lab tests or autopsy results confirming the cause of death were also not reported. There is a possibility that the patient died due to an alternate unrelated infectious etiology. Autopsy results confirming the cause of death would be required to assess the causality with respect to vaccine. Based upon reported information the role of the vaccine cannot be assessed. Reported Cause(s) of Death: headache; muscle pain; Paralysis.


VAERS ID: 747123 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-02-21
Onset:2018-02-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2018-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UFA16026 / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Cyanosis, Death, Heart sounds abnormal, Hyperthermia, Hypopnoea, Loss of consciousness, Purpura, Rales, Respiratory rate decreased, Respiratory tract infection, Vomiting, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (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 (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-02-25
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: UASA2018SA124268

Write-up: Initial unsolicited report received from a healthcare professional via the Regulatory Authority (Partner''s case ID: ICSR001828/1) via partner company LG LIFE SCIENCES (manufacturer control number: UA-LGC-EVX8450) on 20-Apr-2018 and transmitted to Sanofi on 27-Apr-2018. This case involves a six-month-old male patient who was vaccinated with 0.5 ml intramuscular dose of EUVAX B batch number- UFA16026, on 21-Feb-2018 also DTP VACCINE on 31-Jan-2018 and POLIOVACCINE SSI on 21-Feb-2018 batch number- not reported (expiration date, dose in series and site of administration were not reported). Patient''s medical history reported that the child was born at the full term by cesarean section. Baby''s weight at birth 3430g. The condition of child on the Apgar scale was 7/8 points. Concomitant medications were not reported. On 25-Feb-2018 four days following vaccination with EUVAX B, POLIOVACCINE SSI and 25 days following vaccination with DTP VACCINE in the morning (at 8:00), the patient''s body temperature increased to 39 degrees Celsius and was single vomiting. Parents had applied to the medical admission unit and the child was examined by a doctor, Diagnosis indicated Acute respiratory tract infection with hyperthermic syndrome, when viewed 8:00 am, body temperature was checked as 37.5 C. Mother refused from hospitalization, at 15:00 pm, the patient appeared hemorrhagic rash that progressively increased, after 18:00 pm, the parents called an ambulance again, and at 18:55 the child was taken to the hospital. On the same date the child''s condition was extremely critical, was unconscious. The spotty hemorrhagic rash was on the trunk face and extremities heart sounds were weakened, shallow breathing, breathing rate - 36 per minute, auscultatory - breathing sounds are weakened (Breathing rate slowed), vesicular with small bubbling rales in the lower parts of the lungs (Rales) (Respiratory rate decreased). The child''s condition worsened. On same date at 20:20 pm, the patient''s skin was cyanotic and hemorrhagic rash got worse and worse and pronounced cyanosis of fingers. At 21:30 pm, breathing, palpitation and pulse of great vessels were missing (Wheezing). Other laboratory investigations and corrective treatment were not reported. On 25-Feb-2018 at 21:30, patient died. It was unknown if autopsy was performed as Autopsy-determined cause(s) of death was not reported. According to received information the causal relationship between Euvax B and ADR is considered as possible. [Reporter''s comment] There is temporal relationship between the onset of adverse reaction and using of the suspect drug (Euvax B), as well as was using of other suspect drugs (DTP vaccine and Poliovaccine SSI). It is also known that the child was administered suspect drug (Euvax B) before. But taking into account the above symptoms, we can assume that this is very similar to manifestation of meningococcemia, fulminant form. List of the document held by sender: none. Sender''s Comments: This case concerns a 6 month old infant who was reported to have developed signs of cardiopulmonary insufficiency few days after vaccination with EUVAX B, DPT & Polio vaccine SSI, resulting in his death. The time to onset is compatible with the role of the vaccines. However, patient''s congenital anomaly evaluation, medical history, health status at the time of vaccination, autopsy report, and lab tests ruling out alternate etiologies for these events were not provided. Moreover, multiple vaccination use preceded these events. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: Acute respiratory tract infection; Breathing rate slowed; Cyanosis; Death; Heart sounds abnormal; Hypopnoea; Purpura; Rales; Respiratory rate decreased.


VAERS ID: 747588 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR P3A501V / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: UASA2018SA129906

Write-up: Initial unsolicited social media report received from a health authority and employee on 04-May-2018. This case involves a child patient (age, gender unknown), who was vaccinated with vaccination with 0.5 ml IMOVAX POLIO (batch number: P3A501V; expiry date, dose and site of administration were not reported) on an unknown date. Medical history and concomitant medication was not reported. On an unspecified date, after the vaccination, the child passed away. Laboratory investigation and corrective treatment was not reported. It was unknown whether autopsy was done or not. List of the documents held by sender: none. Sender''s Comments: This is poorly documented case which involved a child who died after receiving Imovax polio due to unknown cause. Time to onset is unknown. Additional information including patient details, vaccination details, medical history, condition at the time of vaccination, any other concomitant therapy, previous vaccinations details, autopsy results are missing for further assessment. The same should be requested to complete the assessment.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 747808 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Blood culture positive, Death, Pneumococcal bacteraemia
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immune system disorder; Otitis media; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 2018; Test Name: Blood culture; Result Unstructured Data: Test Result: pathogen material was detected
CDC Split Type: DEPFIZER INC2018186949

Write-up: This is a report from a Non-Interventional study source. A 18 month-old male subject of unspecified race/ethinicity received 3 single doses of PREVENAR 13 for immunization, administered respectively at the age of 4, 6 and 14 months. Medical history included immune defect, as well as urinary tract infections and otitis media. On an unspecified date in 2018 the subject experienced pneumococcal bacteremia without focus. The pathogen material was detected by blood culture. No typing of serotype was determined. The subject had not fully recovered from the adverse event and then died due to it on an unspecified date in 2018. The reporter''s assessment of the causal relationship of the event pneumococcal bacteremia without focus with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: Pneumococcal bacteremia without focus; Pneumococcal bacteremia without focus.


VAERS ID: 747915 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-09-04
Onset:2018-04-02
   Days after vaccination:210
Submitted: 0000-00-00
Entered: 2018-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Dizziness, Encephalopathy, Erythema, Headache, Hypoaesthesia, Limb discomfort, Local reaction, Lymphadenitis, Nausea, Pain in extremity, Seizure, Swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-04-02
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZA0095075131804ZAF002404

Write-up: This spontaneous report was received from a health care professional and was received via medical records, referring to a 26 year old female patient. Information regarding medical history, concurrent conditions or concomitant medication was not provided. On 04-SEP-2017, the patient was vaccinated with the first dose of GARDASIL for prophylaxis, expiration date reported as 2019; (route, lot number and anatomical site of vaccination were not informed). During consultation on 06-NOV-2017, the patient reported that on an unknown date in approximately 2017, she experienced a "suise" and numb arm for a little while after vaccination. On 08-NOV-2017, the patient was vaccinated with the second dose of GARDASIL for prophylaxis, lot number N001994, expiration date May 2019 (route and anatomical site of vaccination were not informed). Later, on an unknown date, she experienced slight local reaction, painful arm, headache and nausea that lasted one day. Then, on 12-MAR-2018, the patient was vaccinated with the third dose of GARDASIL for prophylaxis, lot number N014254, expiration date November 2019 (route and anatomical site of vaccination were not informed). It was also reported that on 02-APR-2018 (reported as date of onset), the patient experienced lymphadenitis, nausea, dizziness, painful arm, redness and swelling. The outcome of lymphadenitis, nausea (onset: 02-APR-2018), swelling, erythema and pain in extremity (onset: 02-APR-2018) was unknown. The outcome of nausea, pain in extremity, local reaction and headache was reported as recovered on an unknown date. The patient recovered from hypoaesthesia and limb discomfort on an unknown date in 2017. The causality assessment between the reported events and therapy with GARDASIL was not provided. Follow up information has been received from the health care professional on 04-MAY-2018. The onset date for lymphadenitis, nausea, dizziness, painful arm, redness, and swelling events was updated from 02-APR-2018 to unspecified dates in 2018. Additionally, the reporter also confirmed that on unspecified dates in 2018 (also reported as date of onset 02-APR-2018; conflicting information), the patient experienced encephalopathy and seizures, requiring hospitalization. Lastly, it was reported that the patient died on 02-APR-2018. It was unknown if an autopsy was performed. The cause of death was not provided. The outcome of encephalopathy and seizure was unknown. The causality assessment between encephalopathy, seizures and death with GARDASIL was described as related (reported as thought to be related to immunisation). Upon internal review the events encephalopathy and seizures were determined to be medically significant. All available medical records will be provided upon request.


VAERS ID: 748622 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:1990-06-01
Onset:1990-09-23
   Days after vaccination:114
Submitted: 2018-05-14
   Days after onset:10095
Entered: 2018-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 1990-09-23
   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: DE2018083831

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of sudden infant death syndrome in a 8-month-old female patient who received DTP (A or W not known) vaccine. In June 1990, the patient received DTP vaccine (unknown). On 23rd September 1990, 87 days after receiving DTP vaccine, the patient experienced sudden infant death syndrome (serious criteria death, GSK medically significant and life threatening). On 23rd September 1990, the outcome of the sudden infant death syndrome was fatal. The patient died on 23 September 1990. The reported cause of death was sudden infant death syndrome. It was unknown if the reporter considered the sudden infant death syndrome to be related to DTP vaccine. Additional details: The age at vaccination was not reported. Anatomical location was not reported. Initial information was received from a physician via regulatory authority on 10th May 2018: Sudden infant death syndrome (SIDS).


VAERS ID: 748627 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-08-07
Onset:2017-08-07
   Days after vaccination:0
Submitted: 2018-05-14
   Days after onset:280
Entered: 2018-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Kawasaki's disease
SMQs:, Vasculitis (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: Gb2018083171

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of Kawasaki''s disease in a 25-week-old male patient who received BEXSERO. On 7th August 2017, the patient received BEXSERO (parenteral). On 7th August 2017, less than a day after receiving BEXSERO, the patient experienced Kawasaki''s disease (serious criteria death and GSK medically significant). On 3rd September 2017, the outcome of the Kawasaki''s disease was fatal. The patient died on 3rd September 2017. The reported cause of death was Kawasaki''s disease. It was unknown if the reporter considered the Kawasaki''s disease to be related to BEXSERO. Initial information was received from a consumer via regulatory authority on 10th May 2018: Kawasaki syndrome leading to death.


VAERS ID: 748997 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-10-05
Onset:2017-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / UN

Administered by: Other       Purchased by: ?
Symptoms: Abnormal behaviour, Altered state of consciousness, Amino acid level abnormal, Amino acid level increased, Ammonia increased, Anion gap increased, Anion gap normal, Biopsy liver abnormal, Blood bicarbonate abnormal, Blood bicarbonate decreased, Blood calcium normal, Blood creatine phosphokinase increased, Blood culture negative, Blood glucose increased, Blood lactic acid increased, Blood phosphorus normal, Blood potassium normal, Blood pressure decreased, Blood pyruvic acid, Blood sodium decreased, C-reactive protein increased, CSF glucose increased, CSF lactate increased, CSF protein increased, Cardiac arrest, Coagulation factor V level normal, Computerised tomogram head abnormal, Death, Endotracheal intubation, Hepatic failure, Hepatic steatosis, Hepatocellular injury, Herpes simplex test negative, Hyperkalaemia, Hypophagia, Hypotonia, Metabolic acidosis, Moaning, Nervous system disorder, Opisthotonus, Procalcitonin increased, Protein total decreased, Protein urine present, Prothrombin level decreased, Prothrombin time ratio decreased, Pyrexia, Resuscitation, Somnolence, Tachycardia, Tachypnoea, Thrombocytosis, Torticollis, Transaminases increased, Urine lactic acid increased, Urine organic acid test, Vaccination site pain, White blood cell count increased, pH body fluid normal, pH urine normal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Lactic acidosis (narrow), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Ocular motility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-09
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Term birth (birth at 40 weeks post last menstrual period)
Allergies:
Diagnostic Lab Data: Test Date: 20171008; Test Name: Ammonia; Result Unstructured Data: Test Result: 56, Test Result Unit: umol/l; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified date): no mutation, no pathogenic alteration.; Test Date: 20171008; Test Name: Anion gap; Result Unstructured Data: Test Result: 27; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified date): no mutation, no pathogenic alteration.; Test Date: 20171008; Test Name: Anion gap; Result Unstructured Data: Test Result: 17; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified date): no mutation, no pathogenic alteration.; Test Date: 20171008; Test Name: CSF bacteria test; Result Unstructured Data: Test Result: 2 nucleated cells, no bacterial infection; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified date): no mutation, no pathogenic alteration.; Test Name: Liver biopsy; Result Unstructured Data: Test Result: moderate and isolated macro vacuolar steatosis; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified date): no mutation, no pathogenic alteration.; Test Date: 20171008; Test Name: Bicarbonate; Result Unstructured Data: Test Result: 11, Test Result Unit: mmol/l; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified date): no mutation, no pathogenic alteration.; Test Date: 20171008; Test Name: Bicarbonate; Result Unstructured Data: Test Result: 14, Test Result Unit: mmol/l; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified date): no mutation, no pathogenic alteration.; Test Date: 20171008; Test Name: Calcium; Result Unstructured Data: Test Result: normal; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified date): no mutation, no pathogenic alteration.; Test Date: 20171008; Test Name: CPK; Result Unstructured Data: Test Result: 2 x UNL; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified date): no mutation, no pathogenic alteration.; Test Date: 20171007; Test Name: Hemoculture; Result Unstructured Data: Test Result: negative; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified date): no mutation, no pathogenic alteration.; Test Date: 20171008; Test Name: Glucose; Result Unstructured Data: Test Result: 12, Test Result Unit: mmol/l; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified date): no mutation, no pathogenic alteration.; Test Date: 20171008; Test Name: Glucose; Result Unstructured Data: Test Result: 2.67, Test Result Unit: g/l; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified date): no mutation, no pathogenic alteration.; Test Date: 20171008; Test Name: Lactate; Result Unstructured Data: Test Result: 5.4, Test Result Unit: mmol/l; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified date): no mutation, no pathogenic alteration.; Test Date: 20171008; Test Name: Phosphorus; Result Unstructured Data: Test Result: normal; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified date): no mutation, no pathogenic alteration.; Test Date: 20171008; Test Name: Potassium; Result Unstructured Data: Test Result: normal; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified date): no mutation, no pathogenic alteration.; Test Date: 20171008; Test Name: Uric acid; Result Unstructured Data: Test Result: 400, Test Result Unit: umol/l; Comments: Heart rate (07Oct2017): tachycardia at 190/mn without associated blood pressure decrease Glucose (08Oct2018): hyperglycemia at 2.67 g/l PCO2 (08Oct2018): 3.3 kPA Brain computed tomography (08Oct2018): bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name) Cerebrospinal fluid lactate (08Oct2018): 4.7mmol/L Cerebrospinal fluid (08Oct2018): 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Urine dip stick (08Oct2018): ruled out glycosuria, ketonuria, leukocyturia and nitrites Plasma amino acid chromatography (unspecified date): citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography(unspecified date): mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy (unspecified date): moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA) (unspecified date): no significant deletion Fibroblasts (unspecified date): normal activity. Liver(unspecified date): activities were normal. Integrity, activity and complete sequencing of mtDNA (unspecified d
CDC Split Type: FRPFIZER INC2018195626

Write-up: This is a spontaneous report from a contactable Health Professional received from the regulatory authority, regulatory authority report number NT20180702. A 4-month-old male patient of an unspecified ethnicity received PREVENAR 13 at single dose and INFANRIX HEXA at 1 DF single, both via an unspecified route of administration on 05Oct2017 for immunisation. Medical history included birth at 40 weeks post last menstrual period, birth weight of 3.170 kg, satisfactory adaptation to extra uterine life. Concomitant medications were not reported (no chronic treatment). The patient developed metabolic acidosis on 07Oct2017, which led to the patient''s death on 09Oct2017 and neurologic disorder, liver failure and hepatocellular injury on 08Oct2017, which could have also participate to the patient death. Course of the events: On 05Oct2017, the patient received pneumococcal 13-valent conjugate vaccine and Diphtheria, Tetanus, acellular Pertussis, Hepatitis b, inactivated Poliomyelitis and conjugated Haemophilus influenzae type b vaccines as vaccination. On 06Oct2017, he developed fever about 38.5 Centigrade. On 07Oct2017, food intake was reduced while behavior change was observed with hypotonia and sleepiness. In the evening, in the emergency room, physical examination revealed painful palpation of vaccination sites, but no neurological abnormality. The patient was hospitalized for tachycardia 190 bpm without associated blood pressure decrease. Blood count showed thrombocytosis 790 000/mm3, blood culture was negative, C reactive protein 120 mg/l and procalcitonin 0.75 ng/ml. On 08Oct2017 in the morning, blood tests revealed hyperglycemia 2.67 g/l, hyponatremia 132 mmol/L, protein 52 g/L, calcium, phosphorus and potassium levels were normal, alkaline reserve decrease to 11 mmol/l. Anion gap was increased to 27. Lactate assay was not performed. The patient was transferred in front of severe neurological distress with opisthotonus, torticollis, pedaling, significant consciousness impairment, moaning and polypnea. Work-up on admission showed compensated metabolic acidosis: pH 7.36, carbon dioxide partial pressure (PCO2) 3.3 kPa, bicarbonates 14 mmHg, anion gap 17, lactates 5.4 mmol/l, blood glucose 12 mmol/l, uric acid 400 umol/L, hepatocellular injury with transaminases at 5 times the upper normal limit, creatine kinase 2 times the upper normal limit, blood ammonium 56 umol/L. Severe neurological distress prompted intubation. Brain computed tomography emergently performed showed bilateral sub and supratentorial hypodense images in the subcortical white matter without contrast uptake, without significant impingement, with lesions which seemed to spread to the lateral ventricle surface. Cerebral arteries were patent, with no caliber abnormality and no sign of cerebral thrombophlebitis. Computed tomography did not evidence intracranial hypertension. There was no bulging fontanel but the patient presented tight miosis while treated with morphine (unspecified trade name). Lumbar puncture was then performed, revealing cerebrospinal fluid protein 1.07 g/L, cerebrospinal fluid glucose 6.1 mmol/L, lactate in cerebrospinal fluid 4.7mmol/L, 2 nucleated cells, no bacterial infection, and polymerase chain reaction for Herpes returned negative. Prothrombin ratio was 67%, coagulation factor II 63%, coagulation factor V 95%. Urine dip stick ruled out glycosuria, ketonuria, leukocyturia and nitrites, urine pH was 5.5, urine protein ++. Antibiotic therapy at meningeal dosing and ZOVIRAX were initiated. Metabolic acidosis gradually aggravated with bicarbonate decrease to 11 mmol/L. Several cardiac arrests required repeated doses of epinephrine, bicarbonates and calcium chloride (unspecified trade names), resulting in transient cardiac activity recovery, but these cardiac arrests subsequently intensified on very deep metabolic acidosis with hyperkalemia. In the context of severe neurological impairment, extracorporeal circulation was not performed. On 09Oct2017, the patient died from metabolic acidosis, with possible involvement of neurologic disorder, liver failure and hepatocellular injury. The parents refused autopsy. Metabolic disease was suspected prompting additional tests which returned negative. Plasma amino acid chromatography revealed citrulline decrease related to gastrointestinal injury with mild increase of phenylalanine in relation with hepatocellular injury. Urine organic acid chromatography found mild increase of lactic acid and pyruvic acid. Acylcarnitine profile was normal. Liver biopsy showed moderate and isolated macro vacuolar steatosis of unspecific pattern, but compatible with mitochondrial disease or other metabolic disease. No significant inflammatory infiltrate, fibrosis or iron deposits were observed. Respiratory pathway was investigated. In the muscle: minimal relative decrease activity of complexes 1, 2 and 4 was noticed along with strong activity of citrate synthase. No significant deletion was found on long range polymerase chain reaction of mitochondrial deoxyribonucleic acid (mtDNA). Fibroblasts showed normal activity. In the liver, activities were normal. Integrity, activity and complete sequencing of mtDNA found no mutation, no pathogenic alteration. Based on the Official Method of Causality Assessment, the causal relationships between pneumococcal 13-valent conjugate vaccine and Diphtheria, Tetanus, acellular Pertussis, Hepatitis b, inactivated Poliomyelitis and conjugated Haemophilus influenzae type b vaccines and the adverse events metabolic acidosis, neurologic disorder, liver failure and hepatocellular injury were assessed by the Agency as "doubtful". No follow-up attempts possible. No further information expected. Information about batch/lot number cannot be obtained. Reported Cause(s) of Death: Neurological disorder NOS; Failure liver; Hepatic cytolysis; Metabolic acidosis.


VAERS ID: 749386 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-10-26
Onset:2017-11-07
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2018-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Unknown       Purchased by: ?
Symptoms: Condition aggravated, Death, Palpitations, Right ventricular failure
SMQs:, Cardiac failure (narrow), Arrhythmia related investigations, signs and symptoms (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen (+) codeine phosphate; atenolol; bumetanide; domperidone
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Palpitations (Had palpitations before but always settled.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131805GBR003991

Write-up: Information has been downloaded from database (GB-MHRA-ADR 24306658). This spontaneous report was received from a physician and refers to a female patient of unknown age. The patient''s historical conditions included palpitations. Had palpitations before but always settled. No information regarding the patient''s concurrent conditions was provided. On 26-OCT-2017, the patient was vaccinated with a dose of ZOSTAVAX standard dose, subcutaneously, (exact dose, indication, lot # and expiration date were not reported). Concomitant therapies included CO-CODAMOL, atenolol, bumetanide and domperidone. On 07-NOV-2017, the patient experienced palpitations. On an unknown date, the patient experienced right heart failure. On an unknown date, the patient was hospitalized and died due to the events. No information regarding autopsy was provided. The outcome of palpitations was also reported as "not recovered". The relatedness between the events and the suspect therapy was not reported.


VAERS ID: 749846 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2018-04-18
Onset:2018-04-18
   Days after vaccination:0
Submitted: 2018-05-22
   Days after onset:34
Entered: 2018-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA973B / UNK UN / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 161501 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R94834 / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB795AB / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-04-19
   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: Domperidone; Lansoprazole; ABIDEC
Current Illness: Unknown
Preexisting Conditions: Nuclear magnetic resonance imaging brain, normal and he did not have epilepsy; Parental consanguinity, non-consanguineous parents; Neuromyopathy, unknown aetiology; Extubation, within first week of life, but remained CPAP dependent thereafter; Respiratory distress, baby was intubated and ventilated
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2018081099

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cardiopulmonary arrest in a 66-day-old male patient who received ROTARIX (batch number AROLB795AB, expiry date unknown). Co-suspect products included INFANRIX HEXA (batch number A21CA973B, expiry date unknown), BEXSERO (batch number 161501, expiry date unknown), PREVENAR 13 (batch number R94834, expiry date unknown). The patient''s past medical history included MRI brain (normal and he did not have epilepsy), parental consanguinity (non-consanguineous parents), neuromuscular disorder NOS (unknown aetiology), extubation (within first week of life, but remained CPAP dependent thereafter) and respiratory distress (baby was intubated and ventilated). Concomitant products included domperidone, lansoprazole and ABIDEC. On 18th April 2018, the patient received ROTARIX (oral), INFANRIX HEXA (intramuscular) .5 ml, BEXSERO (intramuscular) and PREVENAR 13 (intramuscular). On 18th April 2018, less than a day after receiving ROTARIX, INFANRIX HEXA and BEXSERO, the patient experienced ventricular fibrillation (serious criteria death and GSK medically significant). On an unknown date, the patient experienced cardiopulmonary arrest (serious criteria death and GSK medically significant). On 19th April 2018, the outcome of the cardiopulmonary arrest was fatal. On an unknown date, the outcome of the ventricular fibrillation was fatal. The patient died on 19th April 2018. The reported cause of death was cardiopulmonary arrest and ventricular fibrillation. It was unknown if the reporter considered the cardiopulmonary arrest and ventricular fibrillation to be related to ROTARIX, INFANRIX HEXA and BEXSERO. Additional details: Concomitant products include human milk fortifier. The batch number was reported as AZIFC973B for INFANRIX HEXA. However, on review as per the batch number AZIFC973B was corrected to: A21CA973B. Initial information was reported by a physician via regulatory authority on 8th May 2018: cardio-respiratory arrest and ventricular fibrillation. Note: batch number for INFANRIX HEXA was captured as A21CA973B as per the nearest possible match (though the reported batch number AZIFC973B was not matching with any GSK number in accordance with given date of vaccination and respective country). Being database downloaded case, limited information was available and contact to LOC is not possible. Further information might be available on follow up.


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

Administered by: Other       Purchased by: Other
Symptoms: Acute haemorrhagic leukoencephalitis, Computerised tomogram abnormal, Computerised tomogram head abnormal, Computerised tomogram spine, Death, H1N1 influenza, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (narrow), Demyelination (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests were performed on an unspecified date. The patient underwent urgent admission computed tomography (CT) followed by magnetic resonance imaging (MRI) of brain and spine. Contrast enhanced CT (CECT) and high resolution MRI imaging was performed on both 1.5T and 3.0T MR scanners with contrast. MR spectroscopy was also obtained. The patient was diagnosed with H1N1 positive influenza-associated acute encephalopathy. The patient had follow up MRI to assess the disease course and the treatment response. The patient CT and MRI of brain and spine demonstrated necrotizing haemorrhagic encephalopathy on Susceptibility Weighted Imaging (SWI) in basal ganglia and brain stem with tissue necrosis which led to death. The imaging findings reflected the severity of disease from mild to severe.
CDC Split Type: AU2018GSK092682

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


VAERS ID: 750823 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-05-25
Entered: 2018-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Cardio-respiratory arrest, Respiratory distress
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 (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? 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: IT2018GSK090384

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of cardiopulmonary arrest in a 4-month old female patient who received INFANRIX HEXA. Co-suspect products included ROTARIX and PREVENAR 13. On an unknown date, the patient received INFANRIX HEXA at an unknown dose, ROTARIX (oral) and PREVENAR 13 and an unknown dose. On an unknown date, 3 days after receiving INFANRIX HEXA and ROTARIX, the patient experienced cardiopulmonary arrest (serious criteria death and GSK medically significant) and respiratory distress (serious criteria death and GSK medically significant). On an unknown date, the outcome of the cardiopulmonary arrest and respiratory distress were fatal. The reported cause of death was cardiopulmonary arrest and respiratory distress. An autopsy was performed. It was unknown if the reporter considered the cardiopulmonary arrest and respiratory distress to be related to INFANRIX HEXA and ROTARIX. Additional details were provided as follows: The age at vaccination was not reported. No more clinical information was available, so the causal link had not been classified. It was unknown if the reporter considered the cardiopulmonary arrest and respiratory distress to be related to PREVENAR 13 as well. There were ongoing judicial investigations, within and autopsy reply was requested from Agency to the competent authority. The autopsy results had not yet been transmitted. As the case was described on the web no further information was expected.


VAERS ID: 751016 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-05-21
Onset:2018-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR U19348B / 1 UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Choking sensation, Coronary artery disease, Death, Dysphagia, Pulmonary oedema, Resuscitation
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), 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), Other ischaemic heart disease (narrow), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dysphagia; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2018SA140623

Write-up: Initial information received on 23-May-2018 regarding an unsolicited valid serious case received from a nurse. This case involves a 76 years old female patient who experienced pulmonary oedema, coronary artery disease and dysphagia after vaccination with FLUZONE HIGH DOSE. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. Patient had a history of stroke and dysphagia. On 21-May-2018, the patient received a dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine lot U19348B. The patient developed a serious pulmonary oedema following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. This event was leading to death. The patient developed a serious coronary artery disease following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. This event was leading to death. The patient developed a non-serious dysphagia following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. Final diagnosis was dysphagia, (fatal) coronary artery disease and (fatal) pulmonary oedema. An unknown corrective treatment was received. The patient outcome is reported as Fatal on an unknown date for pulmonary oedema, as Fatal on an unknown date for stroke, as Fatal on an unknown date for coronary artery disease. Autopsy was not reported but death certificate was mentioned. The cause of death was reported as Pulmonary oedema and Coronary artery disease. Sender''s Comments: This case concerns a female patient who died a few hours after vaccination with FLUZONE HD. The time to onset is compatible with the role of vaccine. Patient suffered from choking sensation and was provided CPR by her daughter before this fatal outcome. Autopsy was performed and the cause of death was reported to be Pulmonary edema and coronary artery disease. Patient also had a history of stroke and dysphagia in the past. There is no information provided regarding patient''s medical condition at the time of vaccination and there are no lab tests provided that rule out alternate etiologies, particularly cardiovascular causes. Based upon the reported information and considering the past history of the patient, the role of the vaccine cannot be assessed. Reported Cause(s) of Death: pulmonary oedema; coronary artery disease.


VAERS ID: 751024 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Male  
Location: Foreign  
Vaccinated:2018-05-10
Onset:2018-05-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR N1F27 / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Pharyngeal erythema, Pharyngitis, Pyrexia, Respiratory arrest, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-05-14
   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: Medical History/Concurrent Conditions: Cough; Hyperthermia (38 degrees Celsius); Nasal discharge; Pyrexia; Rash erythematous (The patient might have an egg allergy.)
Allergies:
Diagnostic Lab Data: Test Date: 20180412; Test Name: body temperature; Test Result: 38 {DF}; Test Date: 20180510; Test Name: body temperature; Test Result: 36.5 {DF}; Test Date: 20180511; Test Name: body temperature; Test Result: 37.6 {DF}; Test Date: 20180512; Test Name: body temperature; Test Result: 38.1 {DF}; Test Date: 20180512; Test Name: body temperature; Test Result: 38.9 {DF}
CDC Split Type: JPSA2018SA138908

Write-up: Initial unsolicited report received from a physician on 15 May 2018. This case involves a 13 months old male patient who was vaccinated with a dose of ActHIB (batch number, expiration date, dose, route and site of administration were not reported) and MEASLES VACCINE LIVE, RUBELLA VACCINE on 10 May 2018 at 12:00. The patient''s medical history involves, on 11-Nov-2017, the patient had a past history of red narrow rash on the chest and abdomen, which might be caused by egg and resolved. On 09-Apr-2018, pyrexia, cough, nasal discharge developed. On 12-Apr-2018, hyperthermia of 39 degrees Celsius developed, which went down with OZEX, an antipyretic. The patient''s family history was unknown. On 11-May-2018, one-day post vaccination, pyrexia (37.6 degrees Celsius) developed, and then went down to 37 degrees Celsius. After that, nasal discharge developed. On 12-May-2018, two days'' post vaccination, nasal discharge increased. After 11:00, pyrexia of 38.1 degrees Celsius developed. At the time of visiting the reporting clinic, pyrexia increased to 38.9 degrees Celsius. Cough also developed. Acute redness of pharynx also developed. Final diagnosis was acute pharyngitis. On 14-May-2018, at 08:00, the patient''s parent noticed that the patient had not breathed (119 hours after the vaccination) and the patient''s death was confirmed at Hospital A. An antibiotic, OZEX was administered as corrective treatment. It was unknown if an autopsy was performed. List of documents held by sender: none. Sender''s Comments: This case involves 13-month-old male patient, with medical history of egg allergy, and recent fever, cough and nasal discharge treated with antibiotics, received ACTHIB and MEASLES, RUBELLA vaccination. One-day post-vaccination, fever (38.9?C) and nasal discharge occurred. Acute Pharyngitis was diagnosed and treated with antibiotics. Three days after, the patient died. The patient''s birth history, medical condition at the time of vaccination and laboratory tests ruling out alternate etiologies (i.e. infectious disease or others) were not provided. No autopsy was reported. Patient had history of similar events one month prior to vaccination. Additionally, pharyngitis is more likely caused by an infectious etiology. Based upon the reported information, considering the medical history of the patient, nature of events and involvement of two vaccines, the role of an individual vaccine cannot be assessed.


VAERS ID: 751380 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-05-08
Onset:2018-05-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 75033 / 3 UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 75033 / 3 UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER 75033 / 3 UN / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR M75033V / 2 UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-05-09
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BYSA2018SA139294

Write-up: Initial unsolicited report received from a healthcare professional via Health Authority on 17-May-2018. This case involves a four-month-old female patient who was vaccinated with a 0.5 mL third primary dose of IMOVAX POLIO (batch number: 75033, expiry date, route and site of administration were not reported) on 08-May-2018. The patient''s past medical history, medical treatments and family history were not provided. Concomitant medications included 0.5 mL third primary dose of EUPENTA (batch number: 17513, expiry date and site of administration were not reported) intramuscularly on 08-May-2018. On 09-May-2018, one-day post vaccination, the patient died due to sudden death syndrome. It was reported that child did not have any known illnesses, and was not administered any medical products. The patient''s past vaccinations included 0.5 mL first and second primary doses of IMOVAX POLIO and EUPENTA (intramuscularly) between 20-Mar-2018 and 08-May-2018. Relevant lab investigations and corrective treatment were not reported. The cause of death was reported as Sudden death syndrome. It was not reported if autopsy was performed or not. The health Authority assessed the causal relationship with IMOVAX POLIO as possible with the event. List of documents held by sender: none. Follow up report received from a healthcare professional via Health Authority on 18-May-2018. It was reported patient received primary second dose of IMOVAX POLIO with batch number- M75033V, expiry date- Sep-2018 intramuscularly. Patient had no personal medical history. List of documents held by sender: none. Sender''s Comments: Follow up received on 18-May-2018 does not change the previous medical assessment. This case concerns a 4 month old infant who died the next day after receiving IMOVAX POLIO vaccine. Most frequent causes of sudden death in infants include infections, sudden infant death syndrome (SIDS), inherent errors in metabolism, undiagnosed congenital anomalies. It is unknown in an autopsy was conducted. This case being insufficiently documented, further information on the condition/circumstances of the patient at the time of death, medical history (especially if any congenital anomaly), results of investigations etc. will be needed for complete assessment. Without a complete clinical history, no assessment could be made. Noteworthy, SIDS is a common cause of infant mortality without demonstrated relationship with immunization. Reported Cause(s) of Death: Sudden Death Syndrome.


VAERS ID: 751402 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-05-12
Onset:2018-05-13
   Days after vaccination:1
Submitted: 2018-06-01
   Days after onset:19
Entered: 2018-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD233A / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB805AE / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest neonatal, Death
SMQs:, Congenital and neonatal arrhythmias (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2018-05-13
   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: potassium citrate; calcium citrate; trisodium citrate; potassium dihydrogen phosphate, SYTRON; alfacalcidol; indomethacin
Current Illness: Renal tubular acidosis, Type 2
Preexisting Conditions: Klebsiella sepsis; Weight, birth weight 625g.; Retinopathy of prematurity; Premature baby, ex-preterm infant 25+5 weeks
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2018096292

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cardiac arrest neonatal in a 102-day-old female patient who received INFANRIX HEXA (batch number A21CD233A, expiry date unknown). Co-suspect products included ROTARIX (batch number AROLB805AE, expiry date unknown). The patient''s past medical history included klebsiella sepsis, weight (Birth weight 625g.), retinopathy of prematurity and infant premature (Ex-preterm infant 25+5 weeks). Concurrent medical conditions included proximal renal tubular acidosis (Type 2). Concomitant products included alfacalcidol, indomethacin, Trisodium Citrate, potassium citrate, calcium citrate, Potassium Dihydrogen Phosphate, ABIDEC and SYTRON. On 12th May 2018, the patient received INFANRIX HEXA (intramuscular) and ROTARIX (oral). On 13th May 2018, 1 days after receiving INFANRIX HEXA and ROTARIX, the patient experienced cardiac arrest neonatal (serious criteria death, GSK medically significant and life threatening). On 13th May 2018, the outcome of the cardiac arrest neonatal was fatal. The patient died on 13th May 2018. The reported cause of death was neonatal cardiac arrest. It was unknown if the reporter considered the cardiac arrest neonatal to be related to INFANRIX HEXA and ROTARIX. Additional information: The age at vaccination was not reported. However the patient was 102 days old infant at the time of the event. The batch number for ROTARIX was reported as AROLB80JAE. However, on review the reported batch number was corrected from AROLB80JAE to AROLB805AE. Initial information was received from physician via regulatory authority on 30th May 2018: Cardiac arrest neonatal.


VAERS ID: 751580 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Female  
Location: Foreign  
Vaccinated:2017-08-22
Onset:2017-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (HEXAVAC) / SANOFI PASTEUR A21CC7621A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S27539 / UNK UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N000965 / UNK MO / PO

Administered by: Unknown       Purchased by: ?
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: 2017-08-22
   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: Hypersensitivity; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ0095075131805NZL013776

Write-up: Information was obtained on a request by the Company from the agency via a case line listing concerning a 5-month-old female patient. The patient''s concurrent conditions included unspecified allergy. The patient''s pre-existing renal disease, recent surgery, transfusion, X-ray with contrast media, familial and nutritional supplements were unknown. No other pre-existing hepatic disease, other chemicals and other medical conditions were reported. Concomitant therapy and medical history were not reported. On 22-AUG-2017, the patient was vaccinated with ROTATEQ, 2 ml, oral, lot # N000965, expiry date: 04-OCT-2018, for prophylaxis. Other suspect therapies received by the patient on 22-AUG-2017 included Diphtheria toxoid, hepatitis B virus vaccine (unspecified) 0.5 ml, intramuscularly, lot # A21CC761A, expiry date: unknown, hib conj vaccine (unspecified carrier), pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified) and pneumococcal 13v conj vaccine (crm197), 0.5 ml, intramuscularly lot # S27539, expiry date: unknown. On 22-AUG-2017, the patient died (sudden death). Cause of death was unclassifiable. It was unknown whether the autopsy was performed. De-challenge was reported as "no improvement". Causality assessment by the reporter was "unclassified".


VAERS ID: 752033 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-09-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Interstitial lung disease
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131806JPN000190J

Write-up: Initial information has been received from a reporter concerning a male patient in his 70s who in September 2015 was vaccinated with PNEUMOVAX NP for prophylaxis (dose not reported). No other concomitant therapy was reported. In September 2015, the patient received publicly-funded regular vaccination of pneumococcal vaccine, polyvalent (23-valent) at a medical institution within the city. In 2015 (5 days after the vaccination), the patient was hospitalized with suspected interstitial pneumonia (onset of interstitial pneumonia). In 2015 (22 days after the vaccination), the patient died. The cause of death was interstitial pneumonia. At the time of this report, the government could not rule out possible involvement of the vaccination, and decided to pay a survivor''s pension to the patient''s family according to the Relief System for Injury to Health with Vaccination. Reporter''s comment: Not provided. The reporter considered that interstitial pneumonia was serious due to death and hospitalization. Upon internal review, interstitial pneumonia was considered to be serious due to other important medical event. The reporter did not assess the causal relationship of interstitial pneumonia to pneumococcal vaccine, polyvalent (23-valent). Reported Cause(s) of Death: Interstitial pneumonia.


VAERS ID: 752700 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC2018229856

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 2-month-old patient of an unspecified gender received PREVENAR 13, (lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient medical history was not reported. Concomitant medication included PENTAVALENT VACCINE, via unspecified route of administration on unspecified date at a single dose for immunization. It was reported on unspecified date, after vaccination done in health center, the patient had seizure. It was also reported that the patient died on an unspecified date. The outcome of the event seizure was unknown. The cause of death was not reported. It was unknown if an autopsy was performed. Information on lot number, batch number and expiration date has been requested. Sender''s Comments: Based on the information currently available, a contributory role of PREVENAR 13 towards the occurrence of "seizure" cannot be fully excluded considering the known adverse event profile of PREVENAR 13. Currently limited information in this report precludes a full assessment of the case between death and the vaccination. More data such as medical history and event term details especially the time to onset of death, death cause and autopsy results are needed for meaningful medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: patient died.


VAERS ID: 753089 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-08-31
Onset:2017-09-11
   Days after vaccination:11
Submitted: 2018-05-17
   Days after onset:248
Entered: 2018-06-13
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 098637403 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood immunoglobulin E normal, Cardiac failure, Death, Immunodeficiency, Leukaemia, Pneumonia, Pyrexia, Tryptase
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2017-09-15
   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:
Current Illness:
Preexisting Conditions: 22-DEC-2016 to Unknown, Stem cell transplant, stem cell therapy; Unknown to Ongoing, Myelodysplastic syndrome, with excessive blasts
Allergies:
Diagnostic Lab Data: Biochemical investigation: Tryptase and IgE were in the lower laboratory reference range so that an allergic reaction to the vaccine can be excluded.
CDC Split Type: 201701620

Write-up: This serious spontaneous case, was received via Health Authority (DE-PEI-PEI2017080148) on 19-Sep-2017, concerning a 59-year-old, adult, male patient. The patient''s current condition included myelodysplastic syndrome with excessive blasts (since an unspecified date). The patient underwent stem cell transplant on 22-Dec-2016. On 31-Aug-2017, the patient was administered with AFLURIA TIV (dose: 0.5 ml (reported as 1 separate dose), route of administration: intramuscular, batch no: 098637403 (reported as 37403), anatomical location and expiry date: not reported). On 11-Sep-2017, the patient was administered with non-company suspect vaccine REPEVAX (route of administration: intramuscular, batch no: reported as KIA83, (reported as 1 separate dose), anatomical location, and expiry date: not reported). On 11-Sep-2017, after 12 days of vaccination with influenza vaccine, the patient got fever up-to 39 degrees Celsius and his condition worsened. On 12-Sep-2017, after 13 days of vaccination, the patient also developed fatal immunodeficiency/acute immunodeficiency with clinically known leukemia which lasted for 03 days (up to 15-Sep-2017). On 15-Sep-2017, after 18 days of vaccination, the patient also developed Pneumonia and decompensation cardiac. It was reported that, the patient required treatment without hospitalization. The patient died on 15-Sep-2017. On 19-Sep-2017, an autopsy was performed at 09:05 o''clock, on external inspection it showed, ears were formed regularly before and behind the ears there were no irregularities and the external auditory canals were free, no abnormalities or injuries on either wrist surface and both upper arms were without injury and conspicuousness. Internal inspection of cranial cavity showed, no severances of tissue connections or haemorrhages are discernible. The meninges were delicate and free of leaked blood. The so-called cap incision shows the regular anatomical structure of the cerebrum. In the cerebrum and mesencephalon, a distinct pressure cone, as well as flattened cerebral convolutions and blurred furrows was seen. The cardiac cavities as well as the vessels close to the heart were found to contain liquid as well as loosely clotted blood or corpse clots. The foramen ovale was closed. Circumference of the aortic valve was 75 mm, circumference of the mitral valve was 105 mm, circumference of the tricuspid valve was 130 mm, circumference of the pulmonary valve was 90 mm. Ventricular wall thickness dextrally was 3 mm, sinistrally was 18 mm. Heart weight was 410 g. In the anterior descending branch of the left coronary artery, individual fat deposits and low-degree calcifications were visible, which do not obstruct the lumina to a significant degree. Both lungs were large and heavy, the left lung weight 865 g, the right one 815 g. The pleura was delicate and reflective, but of a dark red-blue colour. The spleen was somewhat enlarged; it weight 270 g and had a smooth, reflective capsule. In the stomach, 20 mL of brownish liquid. No crystalline components or tablet residues were found. There were no inflammatory changes or haemorrhages present in the gastric mucosa. In the rectum, greenish pasty faeces. The mucous membrane of the intestine had some blackish discoloration of approximately pinhead size. The renal pelvises were seen with moderate growth of fat, free of inflammatory changes or haemorrhages. The aorta was of regular width in the thoracic section, it showed some fat deposits and only a few calcifications. Major autopsy findings showed massive congestion in the heart and the vessels near the heart, as well as the internal organs. Massively manifest haemorrhagic pulmonary oedema with over hydration and congestion of the pulmonary tissue. Development of a so-called upper inflow congestion with post-mortem lividity in the face as well as the carotid side of the neck, spread out to the chest like a collar. The necropsy provided evidence of cardiac decompensation of unclear genesis underlying the demise. Autopsy was ended at 10:05 o''clock. The autopsy revealed no injection sites, especially no vaccination sites. An acute shock reaction (acute anaphylactic shock of the immediate type) can be excluded due to the temporal relationships between vaccination and death, and the described symptoms. The onset of fever after vaccination that occurred as part of a vaccination reaction, was primarily due to the immune response to the vaccine and does not yet constitute an "allergic" reaction or adverse drug reaction. Nonetheless, to exclude a possible injury from immunisation or an unwanted allergic reaction to the vaccine, biochemical examination of the blood obtained during the autopsy for increased IgE and tryptase values was recommended. The biochemical laboratory markers tryptase and IgE were in the lower laboratory reference range, so that an allergic reaction to the vaccine can be excluded. Subject died because of acute immune deficiency in a condition of clinically known leukemia in a status post stem cell transplantation. For this reason, a bone marrow smear was prepared and a bone marrow chip retained, which can be further examined if necessary. Alternatively, viral inflammation of the pulmonary tissue (viral pneumonia) or another (viral) infection could also be considered as a cause of death, given the pronounced macro-morphologic pulmonary findings. However, these possibilities are unrelated to a vaccination three day before the death. Cause of death was reported as acute cardiac decompensation in case of suspected pulmonary inflammation. Besides cardiac decompensation, the forensic pathologists also speculated that the patient may have died of an acute immunodeficiency, viral pneumonia or viral infection. Manner of death was most likely natural death. The health authority considered this case as serious (death and life threatening). Follow up report received from Health Authority on 22-Sep-2017: The indication of the co-suspect REPEVAX was changed from myelodysplastic syndrome to prophylactic vaccination. Batch no for co-suspect REPEVAX was added. Description to be coded for the event was changed from decreased immune responsiveness to immunocompromised. The cause of death was updated from unknown causes of death to immunodeficiency. It was reported that, the patient required outpatient treatment without hospitalization. The narrative was amended accordingly. Non-significant follow-up received on 11-Oct-2017: No new information received. Non-significant case correction received on 18-Oct-2017: Suspect vaccine AFLURIA QUAD was changed to AFLURIA TIV in narrative. Significant case correction received on 18-Oct-2017: Batch no. of AFLURIA (TIV) was updated to 098637403 and narrative was amended accordingly. Follow up report received on 16-Oct-2017: Added new events as fever, decompensation cardiac, condition worsened, Pneumonia and Immunodeficiency. On 19-Sep-2017, an autopsy was performed and the results were updated. The narrative was amended accordingly. Significant case correction received with IRD 22-Sep-2017: The "Drug Not Administered" field was unchecked in product tab. Case Comment: This case concerns a 59 year old male patient with a history of myelodysplastic syndrome, had died due to fatal immunodeficiency, pneumonia, fever and acute cardiac decompensation, 16 days after receiving a dose of AFLURIA vaccine. Considering the underlying medical condition of myelodysplastic syndrome and available information, the causal role of company suspect vaccine is unlikely. Hence, the causality of events was assessed as not related.


VAERS ID: 753091 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-10-20
Onset:2017-10-23
   Days after vaccination:3
Submitted: 2018-05-31
   Days after onset:220
Entered: 2018-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 35949421A / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Blood count normal, Bronchitis, Death, Dyspnoea, General physical health deterioration, Red blood cell sedimentation rate
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-10-24
   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: Torasemide; Ramipril; Trimipramina; UBRETID; Pantoprazole; Tamsulosin; SEEBRI; Domperidone; Spironolactone; Levomepromazine
Current Illness:
Preexisting Conditions: Pulmonary embolism; Nicotine abuse; 31-May-2018 16:04, Meningitis; Oligophrenia (intellectual disability); COPD; Cardiac disorder; Cardiomyopathy; Schizophrenia; Renal insufficiency
Allergies:
Diagnostic Lab Data: 2On 23-Oct-2017: Pulmonary physical examination was performed, results were not reported. On same day, the subject''s count found to be normal; 3-OCT-2017, Red blood cell sedimentation rate inconclusive, 2mm/1h
CDC Split Type: 201703116

Write-up: This initial serious case, received on 14-Nov-2017, reported by other health professional via health authority (DE-PEI-PEI2017096532) and concerns a 59-year-old, adult, male patient (weight 82.0kg and 198 cm). The historical conditions included meningitis, schizophrenia, nicotine abuse and pulmonary embolism, COPD, cardiac disorder, cardiomyopathy, oligophrenia all from an unspecified date. The patient''s current condition included renal insufficiency (renal insufficiency grade III) (since unspecified date). The patient''s concomitant medications included: Torasemide, ramipril, Trimipramina, UBRETID, pantoprazole, Tamsulosin, SEEBRI, Domperidone, Spironolactone and Levomepromazine. On 20-Oct-2017, the patient was administered with AFLURIA (TIV) (route of administration: subcutaneous, batch number:35949421A, dose: (reported as 1 separate dose), anatomical location, expiry date: not reported). On 23-Oct-2017, 3-4 days (as reported) after vaccination, the patient experienced bronchitis, dyspnea and had afflicted general condition. On the same day, the patient''s blood count was normal, red blood cell sedimentation rate showed 2mm/1h and pulmonary physical examination was performed and results were not reported. On 24-Oct-2017, the patient experienced cardiac arrhythmia. The patient''s treatment measures included inhalation budesonide and inhalation short acting beta agonist (SABA). On the same day (24-Oct-2017) the patient died. The cause of death reported was cardiac arrhythmia. It was reported that, autopsy was not performed. The outcome of the events was reported as fatal. The reporter assessed the causality of the events as unassessable (unclassifiable). The health authority assessed this case as serious (death). Follow up received from a physician via health authority (DE-DCGMA-17175422) on 24-Nov-2017: Added patient''s demographics (weight and height), updated medical history (from current conditions to historical conditions COPD, cardiac disorder, cardiomyopathy, oligophrenia), changed event verbatim of the event reduced general condition to afflicted general condition, changed reported causality from not reported to unassessable. Updated narrative accordingly.


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