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

Case Details

This is page 13 out of 13

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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)

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


VAERS ID: 802616 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-01-15
Onset:2019-01-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2019-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD199A / UNK - / OT
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX756AA / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X46171 / UNK - / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA014CA / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-01-19
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB201903

Write-up: unexpected sudden death 4 days after vaccinations given; This case was reported by a physician via regulatory authority and described the occurrence of sudden infant death in a 13-week-old male patient who received Rota (Rotarix liquid formulation) (batch number AROLA014CA, expiry date unknown) for prophylaxis. Co-suspect products included DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CD199A, expiry date unknown) for prophylaxis, Men B NVS (Bexsero) (batch number ABX756AA, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number X46171, expiry date unknown) for prophylaxis. On 15th January 2019, the patient received Rotarix liquid formulation (unknown), Infanrix hexa (intramuscular), Bexsero (intramuscular) and PREVENAR 13 (intramuscular). On 19th January 2019, 4 days after receiving Rotarix liquid formulation, Infanrix hexa and Bexsero, the patient experienced sudden infant death (serious criteria death and GSK medically significant). On 19th January 2019, the outcome of the sudden infant death was fatal. The patient died on 19th January 2019. The reported cause of death was sudden infant death. An autopsy was performed. It was unknown if the reporter considered the sudden infant death to be related to Rotarix liquid formulation, Infanrix hexa and Bexsero. Additional details: Age at vaccination was not reported however patient could be 12 or 13 weeks old at time of vaccination. Batch number for ROTARIX was reported as AROLCO14CA , however on batch number review it was corrected as AROLA014CA. It was unknown if the reporter considered the sudden infant death to be related to Prevenar 13. Initial information was received from a physician via regulatory authority on 20th February 2019. unexpected sudden death 4 days after vaccinations given. Note: Route of administration for Rotarix was discrepantly reported as Intramuscular however it was supposed to be administered orally.; Reported Cause(s) of Death: Sudden infant death


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)

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


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