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Found 129 cases where Vaccine is MEN or MENB or MENHIB or MNC or MNQ or MNQHIB and Patient Died and Submission Date on/before '2015-09-30'

Case Details

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VAERS ID: 705619 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-07-06
Onset:2017-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER N1D891V / 1 LG / UN
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM

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: 2017-07-07
   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: Prophylactic vaccination
Preexisting Conditions: Comments: Relevant comorbidities including immunity status was reported as unknown.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131707GBR010906

Write-up: Initial unsolicited report received from health care professional on 14-Jul-2017. This case is related to case SW50157l (same reporter). This case involves nine-month-old female patient who was vaccinated with primary dose of PEDIACEL (Batch number: N1D891V, expiration date, dose and route was not reported) in thigh on an unspecified date. The patient''s medical history and concomitant medications were not reported. Relevant comorbidities including immunity status was reported as unknown. On 07 Jul 2017, within 24 hours of receiving PEDIACEL the patient died (cause of death was not reported). The information about autopsy was not reported. The reporter felt the causality between the reaction and the drug. Follow-up report received from health care professional on 18-Jul-2017. It was reported that two-month-old (also reported as 9-week-old) was vaccinated with PEDIACEL as well as primary dose of ROTAVIX and MENINGITIS B and PREVENAR (batch number, expiry date, dose, route and site of administration was not reported for last three vaccines) on 06-Jul-2017. On 06-Jul-2017, on the same day after vaccination, the patient experienced low grade fever at home and was put to bed. It was also reported that patient was fit and well during the vaccination and left the clinic shortly after vaccination. List of documents held by sender: none. Sender''s Comments: Follow-up information received on 18-Jul-2017, changes the previous medical assessment. In this case a 9 weeks old female experienced low grade fever on the same day of vaccination and died within 24 hours of receiving PEDIACEL. The patient was concomitantly vaccinated with ROTAVIX, Meningitis B and PREVENAR vaccines (other manufacturer). No information is provided on conditions at the time of death, sleeping position, patient''s medical history especially any congenital anomaly or prematurity, previous vaccination history, autopsy and results of investigations, etc. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Moreover, as multiple vaccines were administered concomitantly, the role of each component cannot be assessed separately. GB-SA-SW50157L. Reported Cause(s) of Death: Death.


VAERS ID: 709454 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2010-10-25
Onset:2010-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RA / UN

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Autopsy, Cyanosis, Death, Microscopy, Vaccination complication
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNSA2017SA151511

Write-up: Initial unsolicited report received from the literature on 16-Aug-2017. This case was linked with 2017SA151529, 2017SA151538, 2017SA151548. (Same article). The following is the verbatim from the article: Immunization plays an important role in the prevention of infectious diseases and it is currently one of the best measures to prevent diseases. With the implementation of the Expanded Program on Immunization, the types of vaccines have increased and the immunization rate of type 2 vaccines has also increased. The constant public attention paid to suspected abnormal reactions to immunization and the increasing number of negative reports related to vaccines, caused people to be more worried about the safety of vaccines. The improper handling of this matter can easily lead to medical disputes. Past literatures reported that most cases of deaths reported following vaccination are pure coincidences, while there were also some reports that believed vaccines can induce or aggravate potential diseases. This paper determined the cause of death of four infants who died following vaccination through an autopsy of their bodies, determining the relation between the vaccines and cause of death, and providing a reference for reducing the occurrence of coincidental events and the promotion of safe vaccination services. At the same time, it can help to reduce the negative impact of vaccine events and reduce public concerns about vaccination. Materials and Methods: Data Source: The diagnostic data of four cases of deaths following vaccination between January-2010 to December-2016 from an expert group on abnormal reactions to vaccination were collected. The data were taken from the AEFI Surveillance System. Each case has complete birth information, vaccination information, death information, laboratory test results, as well as the autopsy reports. They were all cases of death following vaccination, and the possibility of death by violence and exogenous intoxication was ruled out. Analysis Method: The vaccination units reported the deaths due to suspected abnormal reactions to vaccination to the county-level disease control and prevention institution where the vaccine recipients were located. Either by the fastest methods, such as phone call, within two hours in accordance with the requirements of the "National Suspected Abnormal Reactions to Vaccination Surveillance Program". The county-level disease control and prevention institution immediately submit direct online reports of the cases through the National Immunization Information Management System after verification. Investigation of deaths due to suspected abnormal reactions to vaccination after receiving the report, the municipal center for disease control and prevention immediately organized experts on the diagnosis and investigation of abnormal reactions to vaccination to conduct an investigation and collect vaccination, clinical treatment, death and other related data. The preliminary results of the investigation were reported within seven days. The parents were persuaded to carry out an autopsy during the investigation and the results of the autopsies were recorded. Diagnosis of deaths due to suspected abnormal reactions to vaccination the investigation was carried out by the municipal or provincial expert group on the investigation and diagnosis of abnormal reactions to vaccination. Clinical manifestations, autopsy results and the results of vaccine quality test were combined for a comprehensive analysis and a conclusion was made on the investigation and diagnosis based on the laws, administrative regulations, departmental regulations and technical specifications. Epidemiological analysis a descriptive approach was used to analyze the autopsy results and the investigation and diagnostic data of the death cases. This case involves 12-months-old female patient who was vaccinated with first dose of INFLUENZA VACCINE on the deltoid region of her left upper arm, and second dose of MENINGOCOCCAL POLYSACCHARIDE on the deltoid region of her right upper arm (Batch number, expiry date, dose, and route of administration were not reported for both the vaccines) on 25 Oct 2010 at 11:20:00 A.M. The patient medical history and concomitant medications were not reported. On 25 Oct 2010, 50 minutes after the vaccinations, the patient died due to anaphylactic shock, and the patient also had a cyanosis of the lips and fingernail beds (as per autopsy report). The patient relevant lab tests and corrective treatment were not reported. The patient autopsy revealed that the patient had normal development. A microscopic examination of the laryngeal mucosa revealed vasodilation, congestion, localized tissue edema, inflammatory cell infiltration and the presence of eosinophils. There was diffuse alveolar septal widening, inflammatory cell infiltration and eosinophils in the lungs. Toluidine blue staining indicated an increase in mast cells in the submucosal layer of multiple sites and degranulation of mast cells. Identification of the cause of death: Death caused by anaphylactic shock. The diagnostic conclusion of the municipal expert group on the diagnosis of abnormal reactions was an abnormal reaction to vaccination. Upon internal review the company decided to consider the event as serious due to important medical event cyanosis of the lips and fingernail beds. List of documents held by sender: none. Sender''s Comments: Patient died due to anaphylactic shock 50 minutes after receiving a group A meningococcal polysaccharide and split-virus influenza vaccines. Time to onset is compatible with the role of vaccines. The autopsy revealed that the child had normal development and that here was cyanosis of the lips and fingernail beds. A microscopic examination of the laryngeal mucosa revealed vasodilation, congestion, localized tissue edema, inflammatory cell infiltration and the presence of eosinophils. There was diffuse alveolar septal widening, inflammatory cell infiltration and eosinophils in the lungs. Toluidine blue staining indicated an increase in mast cells in the submucosal layer of multiple sites and degranulation of mast cells. As a result the cause of death was identified as anaphylactic shock however autopsy report was not provided. Additional information including but not limited to the patient anamnesis including allergic history (food allergy and patient''s immunization history are needed to further assess this case. Moreover, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately. Reported Cause(s) of Death: Anaphylactic shock; Autopsy-determined Cause(s) of Death: Anaphylactic shock.


VAERS ID: 719567 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-01-12
Onset:2017-09-01
   Days after vaccination:232
Submitted: 0000-00-00
Entered: 2017-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningococcal infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-09-01
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: RUSA2017SA191699

Write-up: Initial unsolicited report received from a physician on 02-Oct-2017. This case involves a 33-month old patient (age reported as 2.8 years) (gender unknown), who was vaccinated with MENACTRA (batch number, expiry date, dose, route and site of administration was not reported) on 12-Jan-2017. The patient''s ongoing illness / medical history / risk factors were unknown and concomitant medications were not reported. On an unknown date of Sep-2017, few months after the vaccination, patient experienced meningococcaemia serotype C under provisional exclusion according to blood test result, and death happened during 24 hours (date of date also reported as Sep-2017). It was also a case of vaccination failure. Other lab test and corrective treatment was unknown. It was unknown whether autopsy was performed or not. The physician associated death with vaccination failure. Documents held by sender: none.; Sender''s Comments: This case concerns a 2-year-old child who reportedly experienced serogroup C meningococcal infection with a fatal outcome approximately 8 months after receiving MENACTRA vaccine. Vaccination failure may be expected with any vaccine, as no vaccine protects all vaccinated individuals. Relevant information including but not limited to vaccination details (lot number, route, site and actual date of vaccination), vaccination history, patient''s demographics (gender and date of birth), clinical details, the diagnostic tests performed, and the patient''s medical history and immune status (B cell immunity, mannose binding lectin [MBL] and complement status, ...) is lacking to allow adequate medical assessment.; Reported Cause(s) of Death: Meningococcaemia.


VAERS ID: 733227 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Complement deficiency disease, Complement factor C3, Complement factor C4, Complement factor abnormal, Death, Meningococcal infection, Purpura fulminans, Total complement activity decreased, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Congenital, familial and genetic disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-01
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: Medical History/Concurrent Conditions: Cellulitis of face; Measles; Meningitis; Otitis media acute
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRSA2018SA003471

Write-up: Initial unsolicited report received from a literature on 03 Jan 2018. The following is the abstract from the article: We report on the case of fatal "purpura fulminans" caused by Neisseria meningitidis W135 that occurred in a young soldier vaccinated a few months earlier with the tetravalent conjugate vaccine ACYW135. Biological investigations revealed adequate titers of postvaccination antibodies against serogroups A, C, and W135 and led to the post-mortem diagnosis of a complete C7 complement deficiency. Late complement component deficiency is a well-known risk factor of meningococcal diseases, but usually exposes to recurrent mild infections, whereas severe invasive meningococcal diseases are more likely to occur among properdin-deficient patients. Awareness of the potentially life-threatening nature of late complement component deficiency should lead to improved diagnosis among young people, especially when past medical history reveals recurrent mild infections. This case involves 20 years old male patient who was injected with dose of MENINGOCOCCAL VACCINE (TETRAVALENT ACYW135 CONJUGATE MENINGITIS VACCINE) (batch number, expiry date, route and site of administration were not reported) on an unspecified date according to the immunization schedule. His past medical history was significant for several infectious diseases (nondocumented meningitis during childhood, measles and acute otitis media) and a recent case of cellulitis on the face. He had never been sent on any mission outside his country since his integration. Concomitant medication was not reported. On an unspecified date, post vaccination patient had, purpura fulminans caused by Neisseria meningitidis W135. In October 2012, the health authorities notified the Center for Epidemiology and Public Health that a young person had died from purpura fulminans a few hours earlier in a hospital. It was also a case of vaccination failure. Human serum bactericidal activity tests were performed by the Institute laboratory. The patient had an undetectable CH50 level: C3, C4, C5, C6, and C8 levels were normal, but C7 was undetectable. Further biological investigations confirmed the diagnosis of a complete homozygous deficiency in C7 complement, which led to screening among his family (results not available). No sample before the vaccination was available, but post-mortem immunological analysis suggested that the vaccine injection had been followed by an immune response and an increase of antibody titers, except against serogroup Y (human serum bactericidal activity titer at 2). Corrective treatment was not reported. Outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event: Neisseria meningitidis infection NOS. List of documents held by sender: none.; Sender''s Comments: Vaccination failure may be expected with any vaccine, as no vaccine protects all vaccinated individuals. This report of fatal purpura fulminans caused by meningococcemia represents a confirmed vaccine failure to serogroup W135. The patient was an employee (congregate housing such as dorms, etc. is known to increase the risk of contracting Neisseria meningitidis) who had a significant history for several infectious diseases including but not limited to nondocumented meningitis during childhood. Importantly, additional testing revealed complement deficiency (complete homozygous deficiency in C7 complement). Persons who have persistent (i.e., genetic) deficiencies in the common complement pathway have an increased risk for meningococcal disease and can experience recurrent disease. A point of further consideration is that the name of the manufacturer of the specific Meningococcal ACYW135 vaccine was unknown.; Reported Cause(s) of Death: purpura fulminans caused by Neisseria meningitidis W135; Autopsy-determined Cause(s) of Death: purpura fulminans caused by Neisseria meningitidis W135.


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: 753820 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2018-03-26
Onset:2018-05-21
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2018-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 167301 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningococcal bacteraemia
SMQs:, Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEGLAXOSMITHKLINEIE2018GS

Write-up: invasive group B ?meningococcal disease; This case was reported by a other health professional via local affiliate and described the occurrence of meningococcal bacteremia in a 3-month-old female patient who received Men B NVS (Bexsero) (batch number 167301, expiry date unknown) for prophylaxis. On 26th March 2018, the patient received the 1st dose of Bexsero. On 21st May 2018, 56 days after receiving Bexsero, the patient experienced meningococcal bacteremia (serious criteria death and GSK medically significant). On an unknown date, the outcome of the meningococcal bacteremia was fatal. It was unknown if the reporter considered the meningococcal bacteremia to be related to Bexsero. Additional details were provided as follows: This case was received from health care professional (HCP) via GlaxoSmithKline (GSK) employee. Age at vaccination was not reported. The reporter stated that the patient died from invasive group B meningococcal disease. In accordance with the national immunisation programme for Meningococcal B vaccination, the patient was vaccinated with a dose of Bexsero. No other information was provided. Follow up would be sent.


VAERS ID: 765363 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-07-11
Onset:2018-07-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2018-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 3 - / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 2 - / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 - / ID

Administered by: Other       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: 2018-07-13
   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: Paracetamol
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201814

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of sudden death unexplained in a 4-month-old female patient who received INFANRIX HEXA for prophylaxis. Co-suspect products included BEXSERO for prophylaxis and PREVENAR 13 for prophylaxis. Previously administered products included INFANRIX HEXA with an associated reaction of no adverse event, BEXSERO with an associated reaction of no adverse event and PREVENAR 13 with an associated reaction of no adverse event. Additional patient notes included No previous reaction to immunisation. Concomitant products included paracetamol. On 11th July 2018, the patient received the 3rd dose of INFANRIX HEXA (intramuscular), the 2nd dose of BEXSERO (intramuscular) and the 2nd dose of PREVENAR 13 (intramuscular). On an unknown date, less than a month after receiving INFANRIX HEXA and BEXSERO, the patient experienced sudden death unexplained (serious criteria death, GSK medically significant and other: serious per reporter). On 13th July 2018, the outcome of the sudden death unexplained was fatal. The patient died on 13th July 2018. The reported cause of death was sudden death unexplained. It was unknown if the reporter considered the sudden death unexplained to be related to INFANRIX HEXA and BEXSERO. Additional information: The age at vaccination was not reported. However, the patient could be 3 or 4-months-old at the time of vaccination. Initial information was received from a physician via regulatory authority on 8th August 2018: Sudden death unexplained. Reported Cause(s) of Death: Sudden death.


VAERS ID: 771460 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Death
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEGLAXOSMITHKLINEBE2018GS

Write-up: This case was reported by a physician via sales rep and described the occurrence of death in a child patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced death (serious criteria death and GSK medically significant) and coma (serious criteria GSK medically significant). On an unknown date, the outcome of the death was fatal and the outcome of the coma was unknown. The reported cause of death was unknown cause of death. The reporter considered the death and coma to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporting physician was at childhood consultation office and the consulting physician told the reporting physician that last week she had seen parents who had a prescription for BEXSERO vaccine to give to their child. The parents still doubted and asked an advice to the physician. The parents had doubts because the child of one of their friends was vaccinated with BEXSERO and afterwards child went into a coma and died. The parents said that this was due to BEXSERO. Unfortunately, the physician did not know the patient neither where it happened. The sales representative contacted the nearby hospital to find out more about this death but no information was available. Medical Information contacted the sales representative, who provided the name of the physician. Sales representative would try again to contact the reporting physician to obtain the name of the treating physician of the patient who died. The reporter would try to obtain more information. Reported Cause(s) of Death: Death NOS.


VAERS ID: 784823 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-10-19
Onset:2018-10-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX728AA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chronic respiratory failure, Death, Gastrostomy, Hyperthermia, Tachycardia paroxysmal, Terminal state, Tracheostomy
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Accidents and injuries (broad), Cardiomyopathy (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: 2018-10-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NUSINERSEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITGLAXOSMITHKLINEIT201820

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cardiac arrest in a 4-year-old female patient who received BEXSERO (batch number ABX728AA, expiry date unknown) for prophylaxis. Concomitant products included nusinersen. On 19th October 2018, the patient received BEXSERO (unknown) 5 ml. On 19th October 2018 22:00, less than a day after receiving BEXSERO, the patient experienced hyperthermia (serious criteria death). On 19th October 2018 23:00, the patient experienced cardiac arrest (serious criteria death and GSK medically significant), death imminent (serious criteria death and GSK medically significant) and tachycardia paroxysmal (serious criteria death). On 19th October 2018, the outcome of the cardiac arrest, death imminent, tachycardia paroxysmal and hyperthermia were fatal. The patient died on 19th October 2018. The reported causes of death were cardiac arrest, tachycardia paroxysmal, hyperthermia and death imminent. An autopsy was not performed. It was unknown if the reporter considered the cardiac arrest, death imminent, tachycardia paroxysmal and hyperthermia to be related to BEXSERO. Additional information: The route of administration of BEXSERO was reported as Intravenous in the source document. Initial information was received from a physician via regulatory authority on 5th November 2018: Sudden hyperthermia at 10 PM, paroxysmal tachycardia followed by cardiac arrest and death at 11 PM. Reporter''s comments: Clinical report by the signaler: (as per regulations): ''The report refers to a four year old girl Patient affected by SMA Type 1, in integrated home care with chronic respiratory failure in VMI h 24, tracheostomy and PEG. Patient treated with NUSINERSEN given periodically by intrathecal route from 13/01/2017 at the hospital (last administration 14/07/2018). Administered to Patient (truncated sentence). Reported Cause(s) of Death: Cardiac arrest; Tachycardia paroxysmal; Hyperthermia; Death imminent.


VAERS ID: 789365 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2018-11-19
Onset:2018-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX776AA / 2 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Cyanosis, Death, Muscle rigidity, Resuscitation, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Parkinson-like events (narrow), Acute central respiratory depression (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-11-20
   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: Infanrix hexa; Synflorix; Rotavirus vaccine; Bexsero; Infanrix hexa; Synflorix; Rotavirus vaccine
Current Illness:
Preexisting Conditions: Comments: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITGLAXOSMITHKLINEIT2018GS

Write-up: This case was reported by a physician via call center representative and described the occurrence of cardiopulmonary arrest in a 5-month-old male patient who received BEXSERO (batch number ABX776AA, expiry date July 2020) for prophylaxis. Additional patient notes included none. Concomitant products included INFANRIX HEXA, SYNFLORIX, Rotavirus vaccine, BEXSERO, INFANRIX HEXA, SYNFLORIX and Rotavirus vaccine. On 19th November 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 20th November 2018, 1 days after receiving BEXSERO, the patient experienced cardiopulmonary arrest (serious criteria death and GSK medically significant), cyanosis (serious criteria death) and rigidity (serious criteria death). On an unknown date, the outcome of the cardiopulmonary arrest, cyanosis and rigidity were fatal. The patient died on 20th November 2018. The reported cause of death was cardiopulmonary arrest, cyanosis and rigidity. The reporter considered the cardiopulmonary arrest, cyanosis and rigidity to be unrelated to BEXSERO. Additional details were provided as follows: This case was found to be a duplicate of the regulatory case IT-MINISAL02-512448 and all the future corresponding information would be submitted to IT2018GSK214015 (case of record). The Authority reference number for the duplicate case IT-MINISAL02-512448. The patient was born in good clinical conditions, born at term (birth weight as 3.2kg), medical history was negative. In August 2018, the patient received according to National Immunization plan, first doses of INFANRIX HEXA, SYNFLORIX and Rotavirus. No adverse events were reported following these vaccinations. On 20th September 2018, the patient received the first dose of the BEXSERO. On 15th October, 2018, the patient received second doses of INFANRIX HEXA, SYNFLORIX and Rotavirus. Also, after these vaccinations no adverse event were reported. The patient received BEXSERO (not known the precise administration''s hour). The patient came home with his parents and was fine. During the night between 19th and 20th November 2018, the patient''s mother went to his room and realized that the patient was cyanotic and that he was already dead. At night that the parents found the baby in bed cyanotic without breathing. The doctors from emergency diagnosed cardiorespiratory arrest with presence of rigor. CPR until arrival in hospital. The patient''s mother tried to do a cardiac massage, without success, the patient was then taken to the hospital, but he had already passed away. The reporter would inform GlaxoSmithKline of any further detail as soon as they become aware. On 27th November 2018, during follow up from press review the patient demographic details were updated. The press reports that, according to experts who were investigating on the case, the patient''s death was due, at the moment, to the infant''s sudden death syndrome. The expert reports no correlation between the suspect product and the death. Reported Cause(s) of Death: Cardiorespiratory arrest; Cyanosis; Rigidity.


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