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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: 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.


VAERS ID: 790602 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-06-05
Onset:2018-06-01
Submitted: 0000-00-00
Entered: 2018-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Death, Malaise, 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: 2018-06-08
   Days after onset: 7
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: GBGLAXOSMITHKLINEGB201821

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of death unexplained in a 2-month-old male patient who received INFANRIX HEXA for prophylaxis. Co-suspect products included ROTARIX for prophylaxis, BEXSERO for prophylaxis, paracetamol unknown for fever and PREVENAR 13 for prophylaxis. On 5th June 2018, the patient received INFANRIX HEXA(intramuscular), ROTARIX (oral) and BEXSERO (intramuscular). On 6th June 2018, the patient started paracetamol (oral) at an unknown dose and frequency. On 5th June 2018, the patient received PREVENAR 13 (intramuscular). On 8th June 2018, 3 days after receiving INFANRIX HEXA, ROTARIX and BEXSERO and 2 days after starting paracetamol, the patient experienced death unexplained (serious criteria death, GSK medically significant and other: serious per reporter). In June 2018, the patient experienced feeling unwell (serious criteria other: serious per reporter) and high temperature (serious criteria other: serious per reporter). Paracetamol was discontinued on 7th June 2018. On 8th June 2018, the outcome of the death unexplained was fatal. On an unknown date, the outcome of the feeling unwell and high temperature were unknown. The patient died on 8th June 2018. The reported cause of death was unknown cause of death. An autopsy was performed. It was unknown if the reporter considered the death unexplained, feeling unwell and high temperature to be related to INFANRIX HEXA, ROTARIX, BEXSERO and paracetamol. Additional information: It was unknown if the reporter considered the death unexplained, feeling unwell and high temperature to be related to PREVENAR 13. Age at vaccination was not reported, However the patient could be 1 or 2 months old at the time of vaccination. Initial information was received from a physician via regulatory authority on 3rd December 2018: Death unexplained, feeling unwell and high temperature.; Reported Cause(s) of Death: Death unexplained.


VAERS ID: 793321 (history)  
Form: Version 2.0  
Age: 0.92  
Sex: Male  
Location: Foreign  
Vaccinated:2016-10-17
Onset:2016-10-01
Submitted: 0000-00-00
Entered: 2018-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 150201 / UNK - / IM
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / SC
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Apathy, Crying, Encephalitis viral, Fatigue, Hepatic failure, Irritability, Lethargy, Meningitis, Opisthotonus, Pallor, Panencephalitis, Pneumonia, Pyrexia, Somnolence, Thrombocytopenia, Tremor
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (narrow), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131812BRA010453

Write-up: Information has been downloaded from regulatory authority (BR-GLAXOSMITHKLINE-BR2017GSK076666). This spontaneous report was received from a health professional concerning a 11-month-old male patient. The patient''s medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On 17-OCT-2016, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) solution for injection, intramuscularly with reported lot number 155VPN009A (strength, dose, frequency and expiry date were not reported), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) subcutaneously with reported lot number 015N5002 (strength, dose, frequency and expiry date were not reported) and MENJUGATE solution for injection, intramuscularly with reported lot number 150201 (strength, dose, frequency and expiry date were not reported), all three vaccines for prophylaxis. On an unspecified date in October 2016, the patient experienced meningitis, persistent crying, hepatic insufficiency, metabolic disorder, alteration in transaminase, thrombocytopenia, lethargy, pallor, apathy and bronchopneumonia. Also, on an unspecified date in October 2018, a body temperature test was performed to the patient, showing a result of more than or equal to 39 (units not provided). On 18-OCT-2016, the patient experienced prostration condition and fever. On 04-NOV-2016, the patient experienced opisthotonus, somnolence and irritability. On an unspecified date in November 2016, the patient experienced viral encephalitis, trembling in extremities, viral panencephalitis post vaccine and faraway look. Also, on an unspecified date in November 2016, a computerized tomogram head test was performed to the patient (no information was available). On an unknown date, the patient died. It was unknown if an autopsy was carried out. The reported causes of death were hepatic insufficiency and metabolic disorder, with a reported date of end of both events on 08-NOV-2016 (conflicting information). The outcome of opisthotonus, trembling in extremities, alteration in transaminases, viral panencephalitis post vaccine, faraway look, somnolence, thrombocytopenia, irritability, lethargy, pallor, apathy, bronchopneumonia, viral encephalitis, fever, meningitis and prostration condition was reported as unknown (conflicting information as the reporter determined all the aforementioned events to be serious due to death and medically significant). The outcome of crying was reported as recovered (date not provided) (conflicting information as the reporter determined the event to be serious due to death and medically significant). The causality assessment between pneumococcal vaccine (manufacturer unknown) and all the aforementioned events, was reported as unknown. The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and all the aforementioned events, was not provided. The causality assessment between MENJUGATE and all the aforementioned events, was reported as unknown. Lot number 155VPN009A is an invalid lot number for pneumococcal vaccine. Lot number 015N5002 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Reported Cause(s) of Death: Hepatic insufficiency; Metabolic disorder.


VAERS ID: 795436 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-10-24
Onset:2018-10-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD114A / UNK UN / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 172601 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W91639 / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB846BF / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2018-10-26
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201900

Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of death unexplained in a 8-week-old male patient who received INFANRIX HEXA (batch number A21CD114A, expiry date unknown) for prophylaxis. Co-suspect products included BEXSERO (batch number 172601, expiry date unknown) for prophylaxis, ROTARIX liquid formulation (batch number AROLB846BF, expiry date unknown) for prophylaxis and PREVENAR 13 (batch number W91639, expiry date unknown) for prophylaxis. On 24th October 2018, the patient received INFANRIX HEXA (intramuscular), BEXSERO (intramuscular) 1 dosage form(s), ROTARIX liquid formulation (oral) and PREVENAR 13 (intramuscular) 1 dosage form(s). On 26th October 2018, 2 days after receiving INFANRIX HEXA, BEXSERO and ROTARIX liquid formulation, the patient experienced death unexplained (serious criteria death and GSK medically significant). On 26th October 2018, the outcome of the death unexplained was fatal. The patient died on 26th October 2018. 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, BEXSERO and ROTARIX liquid formulation. Additional information: The age at vaccination was not reported. However, the patient could be 8 weeks or less than 8 weeks at the time of vaccination. Initial information was received a other health professional via regulatory authority on 8th January 2019: Child died 2 days after vaccination. I do not think the vaccination was the cause of the death. I have been advised to complete a yellow card and submit to the RA in line with best practice. Reported Cause(s) of Death: Death unexplained.


VAERS ID: 795522 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2018-06-21
Onset:2018-06-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 - / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 - / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Hypotonic-hyporesponsive episode, Irritability, Skin warm, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALPOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201900

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of hypotonic-hyporesponsive episode in a 2-month-old male patient who received INFANRIX HEXA for prophylaxis. Co-suspect products included BEXSERO for prophylaxis, ROTARIX for prophylaxis and PREVENAR 13 for prophylaxis. Concomitant products included CALPOL. On 21st June 2018, the patient received the 1st dose of INFANRIX HEXA (intramuscular), the 1st dose of BEXSERO (intramuscular), the 1st dose of ROTARIX (unknown) and the 1st dose of PREVENAR 13 (intramuscular). On 21st June 2018, less than a day after receiving INFANRIX HEXA, BEXSERO and ROTARIX, the patient experienced hypotonic-hyporesponsive episode (serious criteria death) and sudden death unexplained (serious criteria death and GSK medically significant). On an unknown date, the patient experienced irritable (serious criteria death) and skin warm (serious criteria death). On an unknown date, the outcome of the hypotonic-hyporesponsive episode and sudden death unexplained were fatal and the outcome of the irritable and skin warm were unknown. The reported cause of death was sudden death unexplained and hypotonic-hyporesponsive episode. An autopsy was performed. It was unknown if the reporter considered the hypotonic-hyporesponsive episode, irritable, skin warm and sudden death unexplained to be related to INFANRIX HEXA, BEXSERO and ROTARIX. Additional information: The outcome of Hypotonic-hyporesponsive episode was reported as Not Recovered/Not Resolved. Initial information was received from a physician via regulatory authority on 8th January 2019: Hypotonic-hyporesponsive episode, irritable, skin warm and sudden death unexplained. Note: The date of death was reported as 23rd June 2018. However, the date for sudden death event was reported as 21st June 2018. Reported Cause(s) of Death: Sudden death; Hypotonic-hyporesponsive episode.


VAERS ID: 799754 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-01-13
Onset:2018-10-19
   Days after vaccination:644
Submitted: 0000-00-00
Entered: 2019-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Pyrexia, Sopor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Tachipirina; NUROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mechanical ventilation; Percutaneous endoscopic gastrostomy; Tetraplegia; Tracheostomy
Allergies:
Diagnostic Lab Data: Test Date: 20181019; Test Name: Body temperature; Result Unstructured Data: Test Result: 37,4 international unit(s)-(under 100), Test Result Unit: iu; Test Date: 20181019; Test Name: Body temperature; Result Unstructured Data: Test Result: 39,5 international unit(s)-(under 100), Test Result Unit: iu
CDC Split Type: ITGLAXOSMITHKLINEIT201901

Write-up: Pyrexia; Sopor; This case was reported by a physician via regulatory authority and described the occurrence of fever in a 4-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included NUSINERSEN (SPINRAZA) for spinal muscular atrophy type i. The patient''s past medical history included tracheostomy, tetraplegia, percutaneous endoscopic gastrostomy and mechanical ventilation. Concomitant products included paracetamol (Tachipirina) and ibuprofen (Nurofen). On 19th October 2018, the patient received Bexsero (intramuscular) 1 dosage form(s). On 13th January 2017, the patient received SPINRAZA (intrathecal). On 19th October 2018, less than a day after receiving Bexsero, the patient experienced fever (serious criteria death) and sopor (serious criteria death). On 19th October 2018, the outcome of the fever and sopor were fatal. The patient died on 19th October 2018. The reported cause of death was pyrexia and sopor. It was unknown if the reporter considered the fever and sopor to be related to Bexsero. Additional details: On 19th October 2018 body temperature of patient was reported as 37,4 international unit(s)-(under 100) and 39,5 international unit(s)-(under 100) It was unknown if the reporter considered the pyrexia and sopor to be related to SPINRAZA. Initial information was received from a Physician via regulatory authority on 28th January 2019: On 19/10/2018, at 21 pm hyperthermia 37.3 ? C, administered tachipirina without benefit, BT arrived at 39.8 ? C, given nurofen without benefit, conditions worsened in about 2 hours, drowsiness and then death.; Reported Cause(s) of Death: Pyrexia; Sopor


VAERS ID: 801161 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-02-01
Onset:2019-02-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-02-02
   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: ZASA2019SA033666

Write-up: Patient passed away; rash; Initial information received on 04-Feb-2019 regarding an unsolicited valid serious case received from a nurse. This case involves a 20 months old male patient who had rash and passed away while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. The patient''s past medical history and concomitant medication was not reported. On 01-Feb-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On 02-Feb-2019, one day after the vaccination the patient experienced serious rash and at night passed away. Rash was assessed as medically significant and other event was leading to death. (Other relevant tests included no lab data.) Final diagnosis was rash and (fatal) patient passed away. It was not reported if the patient received a corrective treatment. The event outcome was reported as Fatal on 02-Feb-2019 for patient passed away and as Unknown for rash. It was unknown if an autopsy was done. The cause of death was not reported. List of documents held by sender: none.; Sender''s Comments: This is a case involves a 20 months male who experienced rash one day after vaccination with Menactra and passed away in the night. Patient''s medical history and concomitant medication were not reported. There is no information regarding patient''s medical condition at time of vaccination and previous vaccination history, as well as no investigation results ruling out alternative etiologies. The autopsy report was not provided. Adequate information is not available in this report for a complete medical assessment.; Reported Cause(s) of Death: Death nos


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