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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: 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.


VAERS ID: 861971 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2020-01-01
Submitted: 0000-00-00
Entered: 2020-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BEXSERO
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2020066489

Write-up: Death; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 6-month-old female patient received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVENAR 13) and meningococcal group c tetanus toxoid conjugate vaccine (NEISVAC-C), both via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. Concomitant medication included meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) for immunization. The patient died on Jan2020. The cause of death was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Sender''s Comments: The event death is assessed as related to pneumococcal 13-valent conjugate vaccine and meningococcal group c tetanus toxoid conjugate vaccine and documented as such in the global safety database until sufficient information is available to allow an unrelated causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death cause unknown


VAERS ID: 862947 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Meningococcal infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUGLAXOSMITHKLINEAU2020AP

Write-up: Meningococcal disease leading to death/died of Meningococcal W; This case was reported by a non-health professional via interactive digital media and described the occurrence of meningococcal infection in a 20-year-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced meningococcal infection (serious criteria death and GSK medically significant). On an unknown date, the outcome of the meningococcal infection was fatal. The patient died in January 2020. The reported cause of death was meningococcal infection. It was unknown if the reporter considered the meningococcal infection to be related to Meningococcal B vaccine. Additional case details were reported as follows: The age at vaccination was not reported. The patient received a dose of Meningococcal B vaccine, but the brand was not mentioned. Three weeks before the time of reporting, the patient died due to Meningococcal W. The reporter consented to follow up.; Reported Cause(s) of Death: Meningococcal infection


VAERS ID: 865274 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-05-22
Onset:2017-06-01
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2020-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER 153001 / 1 LL / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Bronchiolitis, Encephalitis, Endotracheal intubation, Intensive care, Polymerase chain reaction positive, Seizure, Sepsis, Tremor
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (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? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Agitation (experinced a week before vaccination); Crying (experinced a week before vaccination); Eye pruritus (which mean flu experinced a week before vaccination)
Allergies:
Diagnostic Lab Data: Test Date: 201706; Test Name: PCR; Result Unstructured Data: Test Result: diagnosed with bronchiolitis, Test Result Unit: unknown
CDC Split Type: BRGLAXOSMITHKLINEBR2020AM

Write-up: bronchiolitis; generalized seizure; lower limbs tremors; anaphylactic shock; sepsis; meningocephalitis; This case was reported by a other health professional via regulatory authority and described the occurrence of anaphylactic shock in a 10-month-old male patient who received Men C NVS (Menjugate Liquid) (batch number 153001, expiry date unknown) for prophylaxis. Co-suspect products included Polio (oral or inactivated unknown) (Polio vaccine) for prophylaxis, Rotavirus vaccine for prophylaxis, 10PN-PD-Dit (Pneumococcal vaccine) for prophylaxis and dtp + hib + ipv for prophylaxis. The patient''s past medical history included crying (experinced a week before vaccination), agitation (experinced a week before vaccination) and eye pruritus (which mean flu experinced a week before vaccination). Previously administered products included paracetamol (administered 6 drops). On 19th June 2017, the patient received the 1st dose of Menjugate Liquid (intramuscular). On 22nd May 2017, the patient received Polio vaccine, Rotavirus vaccine, Pneumococcal vaccine and dtp + hib + ipv at an unknown dose and frequency. In June 2017, less than a week after receiving Menjugate Liquid and 30 days after receiving Polio vaccine, Rotavirus vaccine and Pneumococcal vaccine, the patient experienced anaphylactic shock (serious criteria death, GSK medically significant and other: other as per reporter), sepsis (serious criteria death, GSK medically significant and other: other as per reporter), meningoencephalitis (serious criteria death, GSK medically significant and other: other as per reporter), bronchiolitis (serious criteria hospitalization, GSK medically significant and other: other as per reporter), convulsions generalized (serious criteria hospitalization, GSK medically significant and other: other as per reporter) and tremor limb (serious criteria hospitalization and other: other as per reporter). On an unknown date, the outcome of the anaphylactic shock, sepsis and meningoencephalitis were fatal and the outcome of the bronchiolitis and tremor limb were unknown and the outcome of the convulsions generalized was not recovered/not resolved. The reported cause of death was anaphylactic shock, sepsis and meningoencephalitis. It was unknown if the reporter considered the anaphylactic shock, sepsis, meningoencephalitis, bronchiolitis, convulsions generalized and tremor limb to be related to Menjugate Liquid, Polio vaccine, Rotavirus vaccine and Pneumococcal vaccine. Additional case details were reported as follows: The age at vaccination was 10 months and 13 days. The patient was on breast feeding. The patient received C-conjugated meningococcal in vastus lateralis of left thigh. The patient had receive medical care. Result Positive PCR for Meningitis by Haemophilus influenzae, exam of LAT??S was not performed due to lack of kit. On 20th June 2017, the patient was taken to the hospital but was discharged because child was not experiencing the events reported by parents. On 20th June 2017, at night the patient had second convulsion and parents were retruned to maternity where child was born, he was medicated transferred to another hospital, accepted on Intensive Care unit was intubed and patient presented some PCR and was diagnosed with bronchiolitis. 30 days before starting symptoms, the patient received VIP/VOP, Pentavalent, rotavirus and pneumococcal 10 vaccines. The filling date by immunization program was 7th March 2017. On 19th June 2017, the patient received Meningococcal C vaccine. The patient also received ATT and Anderlane. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information was expected. The follow up was not required.; Reported Cause(s) of Death: Anaphylactic shock; Sepsis; Meningoencephalitis


VAERS ID: 866579 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-06-18
Onset:2020-01-30
   Days after vaccination:591
Submitted: 0000-00-00
Entered: 2020-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER N3C77 / UNK - / OT
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER N3F13 / UNK - / OT
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER P3K824V / UNK - / OT
CEE: FSME-IMMUN. (NO BRAND NAME) / UNKNOWN MANUFACTURER VNR1T08C / UNK - / OT
CEE: FSME-IMMUN. (NO BRAND NAME) / UNKNOWN MANUFACTURER VNR1T058 / UNK - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER AR0625 / UNK - / OT
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX720AA / UNK - / OT
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX738AA / UNK - / OT
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX783BC / UNK - / OT
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER S015572 / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER S000523 / UNK - / OT
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER S015572 / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T65491 / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH W34300 / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AJ5175 / UNK - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. N034380 / UNK - / OT
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R004960 / UNK - / OT
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. R004960 / UNK - / OT
VARCEL: VARICELLA (VARILRIX) / GLAXOSMITHKLINE BIOLOGICALS A70CD348A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Beta haemolytic streptococcal infection, Death, Drug ineffective, Encephalitis, Endocarditis, Haemophilus infection, Influenza, Multiple organ dysfunction syndrome, Myocarditis infectious, Pyrexia, Septic shock, Tracheobronchitis, Vomiting
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Noninfectious encephalitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-02-07
   Days after onset: 8
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: Mannose-binding lectin deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATGLAXOSMITHKLINEAT202005

Write-up: encephalitis; superinfection myocarditis; multiorgan failure; tracheobronchitis; eosinophile Endocarditis; Drug ineffective; septic-toxic shock; bacterial superinfection of lungs and mediastinum (Streptococcus G...; influenza A infection ( Influenza A H1, Influenza a H1-2009); bacterial superinfection of lungs and mediastinum (Streptococcus G...; Pyrexia; Vomiting and high fever; This case was reported by a pharmacist via regulatory authority and described the occurrence of encephalitis in a 21-month-old female patient who received Men B NVS (Bexsero) (batch number ABX720AA, expiry date January 2020) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) (batch number ABX738AA, expiry date February 2020) for prophylaxis, Men B NVS (Bexsero) (batch number ABX783BC, expiry date August 2020) for prophylaxis, Varicella (Varilrix) (batch number A70CD348A, expiry date August 2020) for prophylaxis, MMRVAXPRO (batch number S015572, expiry date unknown) for prophylaxis, MMRVAXPRO (batch number S000523, expiry date unknown) for prophylaxis, MMRVAXPRO (batch number S015572, expiry date April 2021) for prophylaxis, HEXYON (batch number N3C77, expiry date January 2019) for prophylaxis, HEXYON (batch number N3F13, expiry date March 2019) for prophylaxis, HEXYON (batch number P3K824V, expiry date May 2020) for prophylaxis, PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVENAR 13) (batch number T65491, expiry date October 2019) for prophylaxis, PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVENAR 13) (batch number W34300, expiry date 31st March 2020) for prophylaxis, PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVENAR 13) (batch number AJ5175, expiry date unknown) for prophylaxis, ROTAVIRUS VACCINE (ROTATEQ) (batch number N034380, expiry date unknown) for prophylaxis, ROTAVIRUS VACCINE (ROTATEQ) (batch number R004960, expiry date unknown) for prophylaxis, ROTAVIRUS VACCINE (ROTATEQ) (batch number R004960, expiry date October 2019) for prophylaxis, MENINGOCOCCAL GROUP C CONJUGATE VACCINE (NEISVAC-C) (batch number AR0625, expiry date unknown) for prophylaxis, TICK-BORNE ENCEPHALITIS VACCINE (FSME-IMMUN JUNIOR) (batch number VNR1T08C, expiry date November 2020) for prophylaxis and TICK-BORNE ENCEPHALITIS VACCINE (FSME-IMMUN JUNIOR) (batch number VNR1T058, expiry date October 2020) for prophylaxis. The patient''s past medical history included mannose-binding lectin deficiency. On 17th August 2018, the patient received Bexsero (unknown). On 19th October 2018, the patient received Bexsero (unknown). On 7th June 2019, the patient received Bexsero (unknown). On 7th May 2019, the patient received Varilrix (unknown). On 2nd January 2019, the patient received MMRVAXPRO. On 22nd March 2019, the patient received MMRVAXPRO (unknown). On 15th October 2019, the patient received MMRVAXPRO (unknown). On 5th July 2018, the patient received HEXYON (unknown) 1 dosage form(s). On 21st September 2018, the patient received HEXYON (unknown). On 23rd May 2019, the patient received HEXYON (unknown) 1 dosage form(s). On 17th August 2018, the patient received PREVENAR 13 (unknown). On 19th October 2018, the patient received PREVENAR 13 (unknown). On 23rd May 2019, the patient received PREVENAR 13. On 18th June 2018, the patient received ROTATEQ (unknown). On 17th August 2018, the patient received ROTATEQ (unknown). On 21st September 2018, the patient received ROTATEQ (unknown). On 15th October 2019, the patient received NEISVAC-C (unknown). On 2nd May 2019, the patient received FSME-IMMUN JUNIOR (unknown). On 22nd March 2019, the patient received FSME-IMMUN JUNIOR. On 30th January 2020 22:30, 531 days after receiving Bexsero, 468 days after receiving Bexsero, 237 days after receiving Bexsero and 268 days after receiving Varilrix, the patient experienced hemophilus influenza infection (serious criteria death, GSK medically significant and other: Serious as per reporter), influenza a virus infection (serious criteria death and other: Serious as per reporter), bacterial infection due to streptococcus, group a (serious criteria death, GSK medically significant and other: Serious as per reporter), fever and vomiting. On 7th February 2020, the patient experienced septic shock (serious criteria death, GSK medically significant and other: Serious as per reporter), endocarditis (serious criteria death and GSK medically significant) and lack of drug effect. On an unknown date, the patient experienced encephalitis (serious criteria death, GSK medically significant and other: Serious as per reporter), myocarditis infectious (serious criteria death, GSK medically significant and other: Serious as per reporter), tracheobronchitis (serious criteria death and other: Serious as per reporter) and multiorgan failure (serious criteria death, GSK medically significant and other: Serious as per reporter). On an unknown date, the outcome of the encephalitis, septic shock, hemophilus influenza infection, myocarditis infectious, influenza a virus infection, bacterial infection due to streptococcus, group a, tracheobronchitis, endocarditis and multiorgan failure were fatal and the outcome of the lack of drug effect, fever and vomiting were unknown. The patient died on 7th February 2020. The reported cause of death was septic shock, encephalitis, haemophilus influenza infection, myocarditis infectious, influenza a virus infection, bacterial infection due to streptococcus, group a, tracheobronchitis, endocarditis and multi-organ failure. An autopsy was performed. The autopsy determined cause of death was septic shock. It was unknown if the reporter considered the encephalitis, septic shock, hemophilus influenza infection, myocarditis infectious, influenza a virus infection, bacterial infection due to streptococcus, group a, tracheobronchitis, endocarditis, multiorgan failure, lack of drug effect, fever and vomiting to be related to Bexsero, Bexsero, Bexsero and Varilrix. Additional information: The age at vaccination was not reported. It was unknown if the reporter considered the encephalitis, septic shock, hemophilus influenza infection, myocarditis infectious, influenza a virus infection, bacterial infection due to streptococcus, group a, tracheobronchitis, endocarditis, multiorgan failure, lack of drug effect, fever and vomiting to be related to all the doses of Prevenar 13, Hexyon, MMR Vaxpro, Rotateq, FSME-IMMUN JUNIOR and NEISVAC-C. Additional details: As per sender comment, the case was stated to be duplicate of other case. However upon duplicate search no other case was found to be duplicated with this case. Therefore the case was retained and more information about duplicate case is expected in follow up. Initial information was reported by pharmacist via regulatory authority on 26th March 2020: bacterial superinfection of lungs and mediastinum (Streptococcus Group A, Haemophilus Influenza. Sender''s comment: This case is a master made from existing duplicates in Regulatory Authority by the Agency duplicate management team. The case numbers of the underlying duplicates are in the Other Case Identifiers section". The association between the reported fatal events with pneumococcal 13-valent conjugate vaccine can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis.; Reported Cause(s) of Death: Septic shock; Encephalitis; Haemophilus influenza infection; Myocarditis infectious; Influenza A virus infection; Bacterial infection due to streptococcus, group A; Tracheobronchitis; Endocarditis; Multiorgan failure; Autopsy-determined Cause(s) of Death: Septic shock


VAERS ID: 869196 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2019-06-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER YMCA05AB / 1 RL / OT
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER 176VPN008E / 2 RL / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC125AA / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER P3C841V / 2 RL / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER 2201020178 / 2 LL / OT

Administered by: Other       Purchased by: ?
Symptoms: Crying, Death, Lip discolouration, Pallor, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20190716; Test Name: Body temperature; Result Unstructured Data: Test Result: 38, Test Result Unit: degree C
CDC Split Type: BRGLAXOSMITHKLINEBR2020AM

Write-up: COLORFUL LIPS - 3 hours; FEVER 38? - 3 hours/ fever; CRY- 3 hours/ persistent crying; pallor; Death; This case was reported by a other health professional via regulatory authority and described the occurrence of death in a 4-month-old female patient who received Men C NVS (Menjugate Liquid) (batch number YMCA05AB, expiry date unknown) for prophylaxis. Co-suspect products included 10PN-PD-Dit (Pneumococcal vaccine) (batch number 176VPN008E, expiry date unknown) for prophylaxis, Rota (Rotarix liquid formulation) (batch number AROLC125AA, expiry date unknown) for an unknown indication, POLIOMYELITIS VACCINE (INACTIVATED POLIO VACCINE) (batch number P3C841V, expiry date unknown) for prophylaxis and DTP + HB + HIB (batch number 2201020178, expiry date unknown) for prophylaxis. Concurrent medical conditions included breast feeding. On 5th June 2019, the patient received the 1st dose of Menjugate Liquid (intramuscular). On 16th July 2019, the patient received the 2nd dose of Pneumococcal vaccine (intramuscular), the 2nd dose of Rotarix liquid formulation (oral), the 2nd dose of INACTIVATED POLIO VACCINE (intramuscular) and the 2nd dose of DTP + HB + HIB (intramuscular). On an unknown date, less than 3 months after receiving Menjugate Liquid and less than 2 months after receiving Pneumococcal vaccine and Rotarix liquid formulation, the patient experienced death (serious criteria death, GSK medically significant and other: serious per LP assessment), lip color altered (serious criteria hospitalization and other: serious by reporter), fever (serious criteria hospitalization and other: serious by reporter), persistent crying (serious criteria hospitalization and other: serious by reporter) and pallor (serious criteria hospitalization and other: serious by reporter). On an unknown date, the outcome of the death was fatal and the outcome of the lip color altered, fever, persistent crying and pallor were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death, lip color altered, fever, persistent crying and pallor to be related to Menjugate Liquid, Pneumococcal vaccine and Rotarix liquid formulation. Additional details were provided as follows: The patient received Pneumococcal vaccine, Menjugate Liquid and INACTIVATED POLIO VACCINE in vast lateral of right thigh and DTP + HB + HIB in vast lateral of left thigh. The patient was hospitalized on 17th July 2019. Less than 2 months after receiving Pneumococcal vaccine and Rotarix liquid formulation and less than 2 after receiving Menjugate liquid, the patient died. The patient hadd fever of 38 degree C. It was unknown if the reporter considered the death, lip color altered, fever, persistent crying and pallor to be related to INACTIVATED POLIO VACCINE and DTP + HB + HIB. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 869350 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2019-10-07
Onset:2019-10-01
Submitted: 0000-00-00
Entered: 2020-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER P3D901V / 1 - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER AMCA58GA / 1 - / -
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS 181VPN002A / 1 - / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC142AB / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER 2859Y015C / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Pyoderma, Sepsis, Skin necrosis, Tachycardia
SMQs:, Severe cutaneous adverse reactions (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRGLAXOSMITHKLINEBR2020AM

Write-up: sepsis; piodermitis; NECROTIC VIOLACEOUS LESION; Tachycardia; Death; This case was reported by a other health professional via regulatory authority and described the occurrence of death in a 6-month-old male patient who received Men C NVS (Menjugate Liquid) (batch number AMCA58GA, expiry date unknown) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number AROLC142AB, expiry date unknown) for prophylaxis, 10PN-PD-Dit (Synflorix) (batch number 181VPN002A, expiry date unknown) for prophylaxis, DTP + HB + HIB (batch number 2859Y015C, expiry date unknown) for prophylaxis and POLIOMYELITIS VACCINE (POLIO INACTIVATED) (batch number P3D901V, expiry date unknown) for prophylaxis. On 7th October 2019, the patient received the 1st dose of Menjugate Liquid, the 1st dose of Rotarix liquid formulation, the 1st dose of Synflorix, the 1st dose of DTP + HB + HIB and the 1st dose of POLIO INACTIVATED. On 9th October 2019, 2 days after receiving Menjugate Liquid, Rotarix liquid formulation and Synflorix, the patient experienced sepsis (serious criteria death, hospitalization and GSK medically significant), pyoderma (serious criteria death, hospitalization and GSK medically significant), skin necrosis (serious criteria hospitalization and GSK medically significant) and tachycardia (serious criteria hospitalization). In October 2019, the patient experienced death (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the death, sepsis and pyoderma were fatal and the outcome of the skin necrosis and tachycardia were unknown. It was unknown if the reporter considered the death, sepsis, pyoderma, skin necrosis and tachycardia to be related to Menjugate Liquid, Rotarix liquid formulation and Synflorix. Additional details were provided as follows: The age at vaccination was not reported. The patient was not on breastfeeding Child. The patient received medical care.


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