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Found 147 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: 577666 (history)  
Form: Version 1.0  
Age: 1.17  
Sex: Female  
Location: Foreign  
Vaccinated:2015-03-12
Onset:2015-03-31
   Days after vaccination:19
Submitted: 2015-04-24
   Days after onset:24
Entered: 2015-05-11
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Blood electrolytes normal, Body temperature decreased, Breath holding, C-reactive protein increased, Cardiomegaly, Death, Diagnostic procedure, Heart sounds abnormal, Hepatic function abnormal, Hepatomegaly, Infection, Lymphadenopathy mediastinal, Resuscitation
SMQs:, Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol
Current Illness: Immunisation
Preexisting Conditions: Hypertrophic cardiomyopathy; Cardiomegaly; 02/2015, Bronchial hyperreactivity
Allergies:
Diagnostic Lab Data: Blood electrolytes (31-MAR-2015): Normal. 03/31/2015, Body temperature, no temperature; 03/31/2015, C-reactive protein, 4.6; 03/31/2015, Hepatic function abnormal, disorder in liver function; 03/31/2015, Investigation, enlarged liver; 03/31/2015, Investigation, enlarged hypertrophic heart; 03/31/2015, Investigation, gallop rhythm; 03/31/2015, Investigation, mediastinal lymphadenopathy
CDC Split Type: WAES1504NLD020599

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (Case Report N. NL-1577272925-E2015-03678) on 21-APR-2015. Fatal case received from the Health Authorities on 16-Apr-2015 under the reference number NL-LRB-195796. Initial source was a physician from a community health service. Medically confirmed. Case reported as serious by the Agency (category reported by the Agency: results in death). A 14-month-old female patient (weight 9 kg, height 75 cm) had received the first dose of MMRVAXPRO, lot number unknown, subcutaneous route, site of vaccination left upper arm and the first dose of NEISVAC-C, Baxter, lot number unknown, intramuscular route, site of vaccination left thigh on 12-Mar-2015. Concomitant medication was salbutamol since a few weeks. The patient developed an infection (not further specified) on 31-Mar-2015 with a latency of 19 days after vaccination. The clinical course was not clear. About 12 or 14 days after vaccination there was a period of about 5 days of fever, followed by a period of 2 days without fever. At the day the patient died, on 31-Mar-2015, there was an emergency call for medical assistance because of sudden breath holding spells. There was a resuscitation by the general practitioner and after that the patient was transferred to the hospital. The medical history indicated that the patient had bronchial hyperreactivity since Feb-2015 for which she was in follow-up by a pediatrician. The patient had no known past drug therapy. Physical findings and investigations on 31-Mar-2015: gallop rhythm. Autopsy: Enlarged hypertrophic heart. Enlarged liver. Mediastinal lymphadenopathy. Blood and lab results: cultures were deployed, results were not yet known except for CRP 4.6, electrolytes normal, disorder in liver function. No temperature. Preliminary conclusion: fatal infection in a patient with a preexistent serious heart disease. Cause of death unknown for the moment, but possible hypertrophic obstructive cardiomyopathy. Treatment and clinical course: despite resuscitation the patient died 10 minutes after she arrived in the hospital. Causality assessment reported by the Agency: causality for the event infection (not other specified) and both vaccinations was considered not assessable because of the inconsistent information of the latency of the period of fever and the not clear clinical course. It was most likely that the patient had preexistent cardiac problems (enlargement of the heart and hypertrophic cardiomyopathy) and died by an infection. Patient outcome: fatal. Date of death 31-Mar-2015. More information to follow. The following was coded by the Agency: infection. Upon internal review the company judged relevant to code the following adverse events fever and breath holding spells which were mentioned in the narrative but not coded. Noteworthy: the Agency reported that it was unknown if an autopsy was performed, but the narrative reported results of the autopsy: enlarged hypertrophic heart. Enlarged liver. Mediastinal lymphadenopathy.


VAERS ID: 584986 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Female  
Location: Foreign  
Vaccinated:2013-08-19
Onset:2013-08-19
   Days after vaccination:0
Submitted: 2015-07-07
   Days after onset:687
Entered: 2015-07-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER J01101 / UNK UN / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VN920622 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G19208 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Culture negative, Death, Hypoxia, Irritability, Nuclear magnetic resonance imaging, Polymerase chain reaction, Resuscitation, Syncope, Toxicologic test normal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-19
   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: MOVICOL; Unknown
Current Illness:
Preexisting Conditions: Constipation; Vitiligo
Allergies:
Diagnostic Lab Data: 19-AUG-2013, Culture, negative; 19-AUG-2013, Nuclear magnetic resonance imaging, not reported; 19-AUG-2013, Polymerase chain reaction, negative; 19-AUG-2013, Toxicologic test, negative; Weight, 8 kg; Metabolic screen: 19-Aug-2013: not reported; Septic screen: 19-Aug-2013: not reported
CDC Split Type: 2013BAX043887

Write-up: This case was considered invalid as it is a duplicate of 2013315917. This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that it is an initial report. This is a regulatory report of fatal hypoxia, cardiac arrest, apnoea, syncope and irritable in a 5 month old Female patient subsequent to NEISVAC-C (0.5 ml Suspension for injection in pre-filled syringe). This report was received by Regulatory Authorities (reference number: 22297675) via a Physician and forwarded to Baxter. Suspect Product Details: on 19Aug2013 at 1430 hours, the patient received NEISVAC-C, intramuscularly (lot number, dose and injection site were not reported). The patient also received vaccinations with PEDIACEL, intramuscularly and PREVENAR 13, intramuscularly on the same date and time. The lot numbers, doses and injection sites were not reported. The action taken was Not Applicable. Baxter and the Reporter considered PEDIACEL and PREVENAR 13 as co-suspect drugs. Event Details: On 19Aug2013, about four hours after having been vaccinated (1900 hours), the patient became irritable. At an unreported time, the patient experienced syncope (described as collapsed). The patient recovered from the syncope at an unreported time. At 2030 hours, the patient was apnoeic which led to cardiac arrest. The patient was successfully resuscitated by 2110 hours. However, the patient died on 19Aug2013 due to hypoxia (described as severe hypoxic injury). The cause of the cardiac arrest was unknown despite magnetic resonance imaging, toxicology tests, septic screen and a metabolic screen. An unspecified culture and polymerase chain reaction (PCR) were negative, no evidence of sepsis. An autopsy was not performed. Outcome: Hypoxia: Fatal, Cardiac Arrest: Recovered/resolved, Apnoea: Not reported, Syncope: Recovered/resolved, Irritable: Not reported. Medical History: Constipation, Vitiligo. Concomitant Therapy: MOVICOL. Causality Assessment: Unassessible for all suspect products. The reporter stated it was "unclear" whether the vaccinations played any part in the collapse. Follow-up Information (28Feb2014): Additional information was received from a physician. Suspect product information was added or revised. Suspect Product Details: The lot number for NEISVAC-C was VN920622. The lot number for the PEDIACEL used was J0110-1 and the lot number for the PREVENAR 13 that was used was G19208. Follow-up Information (14Apr2014): Batch review results for NEISVAC-C lost number VN920622 were received. The review did not reveal any quality issues. This batch (VN920622) of NEISVAC-C was manufactured and released in compliance with established procedures and specifications. This investigation did not identify any product quality issues with this batch that could be associated with the reported events. Follow-up Information (22May2014): Follow-up information received from the physician. Suspect product details were added (unit dose). Suspect Product Details: On 19Aug2013, at 14:30 the patient received NEISVAC-C one dose (lot number VN920622) administered intramuscularly (site of administration not reported). Follow-up (02Jul2015): This is a follow-up report to notify that the case 2013BAX043887 and 2013315917 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 2013315917.


VAERS ID: 607577 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-05-26
Onset:2015-06-12
   Days after vaccination:17
Submitted: 2015-08-14
   Days after onset:63
Entered: 2015-08-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 144801 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015DE097863

Write-up: Case number PHHY2015DE097863, is an initial spontaneous report from Health Authority (reference number: DE-PEI-PEI2015048324) received on 11 Aug 2015. This report refers to a 28-month-old male patient. Historical conditions were not reported. No concomitant medication was reported. Vaccination history included administration of first dose of BEXSERO (batch number: 144801) on 02 Mar 2015 and the patient tolerated the vaccine well. The patient was vaccinated with the second dose of BEXSERO (batch number: 144801) intramuscularly on 26 May 2015. On 12 Jun 2015, 17 days after receiving the second vaccination, the patient died from an unknown cause. Causality was not reported. It was not reported whether an autopsy was performed.


VAERS ID: 607836 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-21
Entered: 2015-08-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015PR101253

Write-up: Case number PHHY2015PR101253 is an initial spontaneous report received from a consumer (patient''s mother who was a nurse) via sales representative on 14 Aug 2015. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. She was vaccinated with the first dose of MENVEO (batch number: not reported) in 2013. Some months later, she went to doctor''s office as she was not feeling well and was diagnosed with cancer. In 2014, the patient died from cancer. The causality of the event was not reported.


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), Immune-mediated/autoimmune disorders (broad)

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.


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