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Found 146 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: 812213 (history)  
Form: Version 2.0  
Age: 1.58  
Sex: Male  
Location: Foreign  
Vaccinated:2018-08-10
Onset:2019-04-14
   Days after vaccination:247
Submitted: 0000-00-00
Entered: 2019-05-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood culture negative, Blood sodium decreased, C-reactive protein increased, CSF test abnormal, Death, Inappropriate schedule of product administration, Polymerase chain reaction, Pyrexia, Rheumatoid factor negative, Septic shock, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-04-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: sgpt; Test Result: 800 {DF}; Result Unstructured Data: almost 800; Test Name: sgot; Test Result: 800 {DF}; Result Unstructured Data: almost 800; Test Name: sodium; Test Result: 129 {DF}; Result Unstructured Data: 129; Test Name: C-reactive protein; Test Result: 253 {DF}; Result Unstructured Data: 253; Test Name: RA; Test Result: 10 {DF}; Result Unstructured Data: 10
CDC Split Type: LBSA2019SA119194

Write-up: septic shock; high grade fever; vomiting; on 10-aug-2018, the baby received his first dose/on 13-apr-2019, received the second dose; Initial information received on 25-Apr-2019 regarding an unsolicited valid serious case received from a physician. This case involves a 19 months old male patient who experienced septic shock, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was received. On 10-Aug-2018, the patient received a first primary dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On 13-Apr-2019 at 11:20am, he also received second primary dose of the same vaccine with an unknown batch number via intramuscular route in the right deltoid. (Information on the batch number was requested). On 14-Apr-2019, The patient experienced a serious septic shock with symptoms high grade fever (pyrexia) and vomiting 1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. These events were leading to death. The patient was hospitalized after this event occurred. Patient did not have any reaction post first dose. Patient died on 15-Apr-2019 at 07:50 am. It was of actual medication error case due to inappropriate schedule of vaccine administered. The patient should have received the doses atleast three months apart. Relevant laboratory test results included: Alanine aminotransferase - On an unknown date: 800 [almost 800]; Aspartate aminotransferase -: 800 [almost 800]; Blood sodium -: 129; C-reactive protein : 253; Rheumatoid arthritis : 10. Blood culture before antibiotic and PCR CSF resulted negative. Final diagnosis was (fatal) septic shock. It was not reported if the patient received a corrective treatment. It is unknown if an autopsy was done. The cause of death was reported as Septic shock. 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.; Sender''s Comments: This is a case involves a 19-month-old male who suffered Septic shock with symptoms Pyrexia and Vomiting next day following the second primary dose of MENACTRA. The patient was hospitalized and died on the same day due to Septic Shock. Patient tolerated the first dose about 8 months before the second primary dose which also led to the inappropriate schedule of the vaccine. It is always recommended to complete the primary immunization as per approved dosing schedule. Autopsy results are unavailable. Patient was not on any concomitant therapy. Time to onset is however compatible. It was not reported if any corrective therapies were taken. Lab investigations included: Alanine aminotransferase and Aspartate aminotransferase - almost 800; Blood sodium -: 129; C-reactive protein : 253; Rheumatoid arthritis : 10. Blood culture was negative. There is no information on patient''s infectious history, allergy to any product/food along with previous vaccination tolerance (if any). Reassessment with patient''s condition at the time of vaccination, medical history, co-founding factors and autopsy report will be requested to re-assess the role of vaccine.; Reported Cause(s) of Death: septic shock


VAERS ID: 816276 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-04-25
Onset:2019-04-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD309A / UNK - / OT
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX785BB / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AA2786 / UNK - / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC064AA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Epistaxis, Heart rate decreased, Hypopnoea, Loss of consciousness, Mydriasis, Pallor, Pulse abnormal, Rhinorrhoea, Skin discolouration, Sudden infant death syndrome, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-04-26
   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: BCG VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201909

Write-up: Sudden infant death syndrome; Loss of consciousness; Pale skin; Watery nasal discharge; Vomiting; Shallow breathing; Dilated pupils; Heart rate low; Watery nasal discharge; Pulse weak; Skin discoloration; This case was reported by a consumer via regulatory authority and described the occurrence of sudden infant death syndrome in a 8-week-old female patient who received DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CD309A, expiry date unknown) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number AROLC064AA, expiry date unknown) for prophylaxis, Men B NVS (Bexsero) (batch number ABX785BB, expiry date August 2020) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number AA2786, expiry date March 2021) for prophylaxis. Concomitant products included BCG VACCINE. On 25th April 2019, the patient received Infanrix hexa (parenteral) .5 ml, Rotarix liquid formulation (oral) 1.5 ml, Bexsero (parenteral) .5 ml and PREVENAR 13 (parenteral) .5 ml. On 26th April 2019, 1 days after receiving Infanrix hexa, Rotarix liquid formulation and Bexsero, the patient experienced sudden infant death syndrome (serious criteria death and GSK medically significant), loss of consciousness (serious criteria GSK medically significant), pale skin, nosebleed, vomiting, shallow breathing, dilated pupils, heart rate low, nasal discharge watery excessive, pulse weak and skin discoloration. On 26th April 2019, the outcome of the sudden infant death syndrome was fatal. On an unknown date, the outcome of the loss of consciousness, pale skin, nosebleed, vomiting, shallow breathing, dilated pupils, nasal discharge watery excessive, pulse weak and skin discoloration were not recovered/not resolved and the outcome of the heart rate low was unknown. The patient died on 26th April 2019. The reported cause of death was sudden infant death syndrome. It was unknown if the reporter considered the sudden infant death syndrome, loss of consciousness, pale skin, nosebleed, vomiting, shallow breathing, dilated pupils, heart rate low, nasal discharge watery excessive, pulse weak and skin discoloration to be related to Infanrix hexa, Rotarix liquid formulation and Bexsero. Additional details: The age at vaccination was not reported, however the patient could be 7 to 8 weeks at the time of vaccination. The Infanrix hexa batch number was reported as A2HD309A . However based on a batch number review, it was change to A21CD309A. The Rotarix batch number was reported as AROLCO64AA. However based on a batch number review, it was change to AROLC064AA. Initial information was reported by a consumer via regulatory authority on 23rd May 2019: Sudden infant death syndrome, loss of consciousness, pale skin, nosebleed, vomiting, shallow breathing, dilated pupils, heart rate low, nasal discharge watery excessive, pulse weak and skin discoloration.; Reported Cause(s) of Death: Sudden infant death syndrome


VAERS ID: 818508 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-10-03
Onset:2019-03-20
   Days after vaccination:533
Submitted: 0000-00-00
Entered: 2019-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningitis, Neisseria test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-03-20
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Serology test; Result Unstructured Data: Test Result: Serogroup B positive, Test Result Unit: unknown
CDC Split Type: IEGLAXOSMITHKLINEIE2019EM

Write-up: Vaccination failure; Meningitis B; This case was reported by a other health professional and described the occurrence of vaccination failure in a 19-month-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. Co-suspect products included Men B NVS (Meningococcal B vaccine) for prophylaxis and Men B NVS (Meningococcal B vaccine) for prophylaxis. On 3rd October 2017, the patient received the 1st dose of Meningococcal B vaccine. On 17th December 2017, the patient received the 2nd dose of Meningococcal B vaccine. On 3rd August 2018, the patient received the 3rd dose of Meningococcal B vaccine. On 20th March 2019, 1 year and 168 days after receiving Meningococcal B vaccine, 1 year and 93 days after receiving Meningococcal B vaccine and 229 days after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningitis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningitis was fatal. The patient died on 20th March 2019. The reported cause of death was meningitis. It was unknown if the reporter considered the vaccination failure and meningitis to be related to Meningococcal B vaccine, Meningococcal B vaccine and Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not provided. There had been Men B vaccine failure reported recently this year till the day of reporting This case was linked to case IE2019EME102212 reporter by same reporter. Lab Comments: Lab test performed on an unknown date; Reported Cause(s) of Death: Meningitis


VAERS ID: 819148 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-04-29
Onset:2019-05-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD251A / UNK - / OT
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX790AB / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AD6190 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Condition aggravated, Death, Dyspnoea, Respiratory acidosis, 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), Pulmonary hypertension (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: 2019-05-04
   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: Ranitidine; Furosemide; Amiloride hydrochloride; Lactulose; Captopril
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchiolitis (In February 2019); Cough (Predated vaccinations); Foramen ovale patent; Ventricular septal defect (Born with, was repaired at 4 months of age)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201910

Write-up: Condition aggravated; Cardiac arrest; Respiratory acidosis; Respiratory distress; Breathing difficult; This case was reported by a physician via regulatory authority and described the occurrence of cardiac arrest in a 5-month-old female patient who received DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CD251A, expiry date unknown) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) (batch number ABX790AB, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number AD6190, expiry date unknown) for prophylaxis. The patient''s past medical history included cough (Predated vaccinations), ventricular septal defect (Born with, was repaired at 4 months of age) and bronchiolitis (In February 2019). Concurrent medical conditions included foramen ovale patent. Concomitant products included ranitidine hydrochloride (Ranitidine), frusemide (Furosemide), amiloride hydrochloride, lactulose and captopril. On 29th April 2019, the patient received Infanrix hexa (intramuscular) 1 dosage form(s), Bexsero (intramuscular) 1 dosage form(s) and PREVENAR 13 (intramuscular) 1 dosage form(s). On 1st May 2019, 2 days after receiving Infanrix hexa and Bexsero, the patient experienced respiratory distress (serious criteria GSK medically significant) and breathing difficult. On 4th May 2019, the patient experienced cardiac arrest (serious criteria death and GSK medically significant) and respiratory acidosis. On an unknown date, the patient experienced condition worsened. On 4th May 2019, the outcome of the cardiac arrest was fatal. On an unknown date, the outcome of the respiratory distress, condition worsened and respiratory acidosis were unknown and the outcome of the breathing difficult was not recovered/not resolved. The patient died on 4th May 2019. The reported cause of death was cardiac arrest. It was unknown if the reporter considered the cardiac arrest, respiratory distress, condition worsened, breathing difficult and respiratory acidosis to be related to Infanrix hexa and Bexsero. Additional information: The age at vaccination was not reported, however the patient could be 4 or 5 month old at the time of vaccination. It was unknown if the reporter considered the cardiac arrest, respiratory distress, condition worsened, breathing difficult and respiratory acidosis to be related to Prevenar 13. The concomitant product reported as Nutritional supplement. Initial information was reported by a physician via regulatory authority on 12th June 2019: Cardiac arrest, respiratory distress, condition worsened, breathing difficult and respiratory acidosis. Note: The reported current condition Cough was changed to historical condition as the patient was died.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 831139 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VNS1S12D / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W19703 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2019354059

Write-up: death; This is a spontaneous report from a contactable Other Health Professional from the local Regulatory Authority (Regulatory Authority ES-AEMPS-533524). A 4-month-old male patient received meningococcal group C tetanus toxoid conjugate vaccine (NEISVAC-C, lot#: VNS1S12D) and pneumococcal 13-valent conjugated vaccine (dipht crm197 protein) (PREVENAR 13, lot#: W19703), both via an unspecified route of administration on an unspecified date at single dose for vaccination, and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (INFANRIX HEXA, lot#: A21CD077A), via an unspecified route of administration on an unspecified date at unspecified dose for vaccination. The patient had no relevant medical history. The patient''s concomitant medications were not reported. The patient experienced death on an unspecified date the night after vaccination. An autopsy was performed and results were not provided.; Reported Cause(s) of Death: death


VAERS ID: 832744 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-06-03
Onset:2019-08-02
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2019-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD077A / UNK - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VNS1S12D / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W19703 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Crying, Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (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? No
Previous Vaccinations:
Other Medications: VITAMIN D3; APIRETAL
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZERINC2019354059

Write-up: fever; Persistent crying; This is a spontaneous report from a contactable Other Healthcare Professional (HCP) from the local Regulatory Authority and later downloaded from the Regulatory Authority (ES-AEMPS-533524). The Regulatory Authority report number is ES-AEMPS-533524. A 4-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) (lot# W19703, Exp date Sep2019) via an unspecified route of administration on 02Aug2019 at single dose for vaccination; meningococcal group C tetanus toxoid conjugate vaccine (NEISVAC-C) (lot# VNS1S12D, Exp date May2021) via an unspecified route of administration on 02Aug2019 at single dose for vaccination and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (INFANRIX HEXA) (lot# A21CD077A) via an unspecified route of administration on 02Aug2019 at unspecified dose for routine vaccination, Vitamin D3 pharma 2.000 UI/ml oral solution from 03Jun2019, paracetamol (APIRETAL 100 mg/ml oral solution) oral on 02Aug2019 for fever. The patient had no relevant medical history. The patient''s concomitant medications were not reported. The patient experienced fever from 02Aug2019 and persistent crying from 02Aug2019 that resulted in death. The patient was died on an unspecified date the night after vaccination (as reported). An autopsy was performed and results were not provided. Investigational results for Prevenar 13 lot# W19703 and NeisVac-C lot# VNS1S12D. Conclusion for Neisvac-C lot# VNS1S12D: there is no evidence to suggest that the reported Adverse Event is related to Manufacture, Packing or storage activities. Pfizer will take no further action at this time. Conclusion for Prevenar 13 lot# W19703: Packed lot W19703 and associated bulk lot 930214, met all Quality and compliance requirements at the time of release. There is no evidence to suggest that the reported Adverse Event is related to Manufacture, Packing or storage activities. Pfizer will take no further action at this time. Follow-up (19Aug2019): New information from the same contactable Other HCP received from local Product Quality Complaint group includes expiry date for the vaccine was provided. Follow-up (20Aug2019): New information from the same contactable Other HCP reported by the local Regulatory Authority included: the autonomous community code. Follow-up (23Aug2019, 23Aug2019): New information received from Product Quality Complaints Group includes: investigational results for Prevenar 13 lot# W19703, and NeisVac-C lot# VNS1S12D. No follow-up attempts are possible. No further information is expected. Follow-up (28Aug2019): New information from a physician downloaded from the Regulatory Authority (ES-AEMPS-533524) included: patient''s weight, reaction data (previously reported event "death" was deleted and replaced with new events fever and persistent crying, cause of death), and product details (vaccination date, additional suspect products Vitamin D3, paracetamol). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever; Persistent crying


VAERS ID: 846868 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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: BRSA2019SA311790

Write-up: a patient died after receiving the product MENINGOCOCCAL VACCINE; Initial information received on 07-Nov-2019 regarding an unsolicited valid serious death case received from a consumer/non-hcp. This case involves a patient who was died after receiving the product meningococcal vaccine MENINGOCOCCAL VACCINE (death NOS). The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient died after receiving the product meningococcal vaccine (death) (Unknown latency) following the administration of MENINGOCOCCAL VACCINE. This event was assessed as medically significant and was leading to death. The reporter couldn''t inform which vaccine was used. Lab data was not reported. Final diagnosis was Death NOS. It was not reported if the patient received a corrective treatment. The patient outcome was reported as fatal. It is unknown if an autopsy was done. The cause of death was reported as Death. Information on batch number is requested.; Sender''s Comments: This case concerns a patient who died after the vaccination with MENINGOCOCCAL VACCINE (unknown manufacturer). The time to onset is unknown. The patient''s past medical history, concomitant medications and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: death NOS


VAERS ID: 852773 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-21
Onset:2019-11-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD450A / UNK - / OT
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX7ABAA ? / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AN3638 / UNK - / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC259AE / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-22
   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: SYTRON
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201922

Write-up: Death; This case was reported by a physician via regulatory authority and described the occurrence of death unexplained in a 8-week-old female patient who received DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CD450A, expiry date unknown) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number AROLC259AE, expiry date unknown) for prophylaxis, Men B NVS (Bexsero) (batch number abx7abaa ?, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number AN3638, expiry date unknown) for prophylaxis. Concomitant products included sodium feredetate (Sytron) and vitamins nos (Dalivit). On 21st November 2019, the patient received Infanrix hexa (unknown), Rotarix liquid formulation (unknown), Bexsero (intramuscular) and PREVENAR 13 (unknown). On 22nd November 2019, 1 days after receiving Infanrix hexa, Rotarix liquid formulation and Bexsero, the patient experienced death unexplained (serious criteria death and GSK medically significant). On 22nd November 2019, the outcome of the death unexplained was fatal. The patient died on 22nd November 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death unexplained to be related to Infanrix hexa, Rotarix liquid formulation and Bexsero. Additional details: The age at vaccination was not reported. The reported batch number abx7abaa for bexsero did not match with GSK lot number. Initial information was received from a physician via regulatory authority on 11 December 2019: Death unexplained.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 852774 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-10-15
Onset:2019-10-29
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2019-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABXA40AB / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haematoma, Computerised tomogram head abnormal, Death, Haematoma, Pallor, Somnolence, Subdural haematoma, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-10-31
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Upper respiratory tract infection (on 11th October 2019)
Allergies:
Diagnostic Lab Data: Test Date: 20191029; Test Name: Body temperature; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 20191030; Test Name: Brain computerized tomography; Result Unstructured Data: Test Result: expanded subdural and cerebral haematoma, Test Result Unit: unknown
CDC Split Type: HUGLAXOSMITHKLINEHU201922

Write-up: expanded subdural haematoma; expanded cerebral haematoma; vomited three times; pallor; 4 fingertip-size haematomas on the chest; somnolence; This case was reported by a physician via regulatory authority and described the occurrence of subdural haematoma in a 3-month-old female patient who received Men B NVS (Bexsero) (batch number ABXA40AB, expiry date unknown) for meningococcal immunization. Co-suspect products included PENTAXIM (batch number ROB 851, expiry date unknown) for prophylaxis and MENINGOCOCCAL GROUP C CONJUGATE VACCINE (NEISVAC-C) (batch number ARO6561, expiry date unknown) for prophylaxis. The patient''s past medical history included upper respiratory tract infection (on 11th October 2019). On 15th October 2019, the patient received Bexsero (intramuscular) .5 ml. On 1st October 2019, the patient received PENTAXIM (intramuscular) .5 ml and NEISVAC-C (intramuscular) .5 ml. On 29th October 2019, 14 days after receiving Bexsero and 28 Day after receiving PENTAXIM and NEISVAC-C, the patient experienced vomiting (serious criteria death), pallor (serious criteria death), haematoma (serious criteria death) and somnolence (serious criteria death). On 30th October 2019, the patient experienced subdural haematoma (serious criteria death and GSK medically significant) and cerebral haematoma (serious criteria death and GSK medically significant). On 31st October 2019, the outcome of the subdural haematoma, cerebral haematoma, vomiting, pallor, haematoma and somnolence were fatal. The patient died on 31st October 2019. The reported cause of death was vomiting, pallor, subdural haematoma, cerebral hematoma, hematoma and somnolence. It was unknown if the reporter considered the subdural haematoma, cerebral haematoma, vomiting, pallor, haematoma and somnolence to be related to Bexsero. Additional details: The age at vaccination was not reported, however the patient was 2 or 3-month-old at the time of vaccination. It was unknown if the reporter considered the subdural haematoma, cerebral haematoma, vomiting, pallor, haematoma and somnolence to be related to Neisvac-C and Pentaxim. On 30th October 2019, CT brain scan showed expanded subdural and cerebral haematoma. On 29th October 2019, Body temperature was normal. Initial information was reported by a physician via regulatory authority on 11th December 2019: Vomited three times, subdural haematoma, cerebral haematoma, vomiting, pallor, haematoma and somnolence. Sender''s comments : According to the SmPCs, vomitus and somnolence are expected adverse events of BEXSERO, PENTAXIM and NEISVAC-C. Pallor is expected for BEXSERO. Cutaneous haematoma is rare adverse event of NEISVAC-C, listed in the product information. Subdural and cerebral haematomas are considered unexpected events. The events occured around the same time, which is suggestive of a common etiology, vomitus, somnolence and pallor is presumably related symptoms of haematomas. Chest subduraland cerebral haematomas are suggestive of an excessive bleeding by the patient. Time to onset was 14 days for BEXSERO and 28 days for PENTAXIM and NEISVAC-C. Due to lack of close temporality and fatal symptoms that are not typical for adverse reactions after vaccination, causal relationship between BEXSERO, PENTAXIM, NEISVAC-C and the reported adverse events (vomitus, pallor, somnolence, chest-, subdural- and cerebral haematomas) is assessed unlikely. The case is considered serious due to fatal outcome. Further information is expected from the national competent authority for vaccines.; Reported Cause(s) of Death: Vomiting; Pallor; Subdural haematoma; Cerebral haematoma; Haematoma; Somnolence


VAERS ID: 858738 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-12-20
Onset:2019-12-01
Submitted: 0000-00-00
Entered: 2020-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningitis pneumococcal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Bexsero
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRGLAXOSMITHKLINEFR202001

Write-up: Pneumococcal meningitis; Fever; Death; This case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a 6-month-old female patient who received Men B NVS (Bexsero) for prophylaxis. Concomitant products included Men B NVS (Bexsero). On 20th December 2019, the patient received the 2nd dose of Bexsero. In December 2019, less than a week after receiving Bexsero and an unknown time after receiving Bexsero, the patient experienced pneumococcal meningitis (serious criteria hospitalization and GSK medically significant) and fever (serious criteria hospitalization). On 24th December 2019, the patient experienced unknown cause of death (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the pneumococcal meningitis and fever were unknown. It was unknown if the reporter considered the unknown cause of death, pneumococcal meningitis and fever to be related to Bexsero. Additional deatils were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Bexsero 2 months before 2nd dose. Four days after vaccination with 2nd dose of Bexseo, the patient had death. After vaccination. patient experienced fever and hospitalised and documented with pneumococcal meningitis. The reporter stated that, It was unknown whether or not the pneumococcal meningitis was the reason for the death. The reporter stated that the final report on the death was under process and should be issued in 2 weeks now on. The physician did not agree to follow with safety as the final medical document was not prepared yet. It was expected to be available in two weeks on and then the physician may reconsider her decision for a follow up with safety Glaxosmithkline. The reporter did not consent to follow up.


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