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VAERS ID: 862731 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2010-06-03
Onset:2010-06-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2020-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA672A / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D02112 / UNK - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asphyxia, Autopsy, Brain injury, Cardiac arrest, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-06-07
   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: Immunisation; Immunization
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075132002AUS006931

Write-up: Hypoxic brain damage consistent with positional asphyxia; cardiac arrest; Information has been downloaded from authority (AU-PFIZER INC-2011119149). This literature marketed report has been received from author of the literature article entitled as stated below refers to a 6 week old male patient. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On 03-JUN-2010, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) (lot # AROLA09 (invalid lot) and expiration date was not provided) 1 dosage form, single, orally for immunisation. On the same day, the patient also administered with other co-suspect therapies which included, pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVENAR) solution for injection in pre-filled syringe (lot# D02112 and expiration date reported as February 2013) 1 dosage form, single for immunization and hib conj vaccine (tet toxoid), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (INFANRIX HEXA) (lot# A21CA672A and expiration date was not provided) 1 dosage form for immunization. On 06-JUN-2010, 4 days after onset of therapy the patient experienced hypoxic brain damage consistent with positional asphyxia (brain injury) and cardiac arrest. Approximately on an unknown date in June 2010, the patient was hospitalized due to the events. On 07-JUN-2010, the patient died of cardiac arrest and brain injury. An Autopsy was performed. The outcome of brain injury and cardiac arrest was reported as fatal. Causality assessment was not provided. A copy of the published article is attached as further documentation of the patient''s experience. Literature Report: Investigation of Prevenar and deaths in children in this country: what does it mean for other countries?. prescriber. Sender''s Comments: AU-PFIZER INC-HQWYE904905AUG03: AU-PFIZER INC-AUWYE355224SEP07: AU-PFIZER INC-AU-WYE-G06183310: AU-PFIZER INC-2011119243:; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: Hypoxic brain damage


VAERS ID: 862921 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-01-04
Onset:2011-01-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Encephalopathy, Hyperthermia, Myocarditis
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Accidents and injuries (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRGLAXOSMITHKLINEKR2020AP

Write-up: Encephalopathy; Myocarditis; Hyperthermia; This case was reported by a other health professional via regulatory authority and described the occurrence of encephalopathy in a 1-year-old female patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included Polio (oral or inactivated unknown) (Polio vaccine) for prophylaxis. On 4th January 2011, the patient received Infanrix and Polio vaccine. On 4th January 2011, less than a day after receiving Infanrix and Polio vaccine, the patient experienced hyperthermia (serious criteria death). On an unknown date, the patient experienced encephalopathy (serious criteria death and GSK medically significant) and myocarditis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the encephalopathy, hyperthermia and myocarditis were fatal. The reported cause of death was encephalopathy, hyperthermia and myocarditis. It was unknown if the reporter considered the encephalopathy, hyperthermia and myocarditis to be related to Infanrix and Polio vaccine. Additional details were received as follows: Agency has been made aware of this case on 1st February 2010. The age at vaccination was not reported.; Reported Cause(s) of Death: Encephalopathy; HYPERTHERMIA; MYOCARDITIS


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: 863006 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-01-09
Onset:2020-01-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH X63656 / 1 RL / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Crying, Cyanosis, Death, Dehydration, Dyspnoea, Gastroenteritis adenovirus, Hypotonia, Laboratory test, Meningitis, Moaning, Otitis media, Pulse absent, Purulent discharge, Pyrexia, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-01-11
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUM; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dehydration (Hospitalization 06-16.12.2019); Enteritis due to adenovirus (Hospitalization 01-05.12.2019); Urinary tract infection, site not specified (Hospitalization 06-16.12.2019)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: 38.5-38.9, Test Result Unit: Centigrade
CDC Split Type: PLPFIZER INC2020079748

Write-up: Purulent meningitis secondary to otitis media (left ear); Purulent meningitis secondary to otitis media (left ear); Cardiac arrest; Moaning; No muscle tone; Respiratory arrest; Crying; Cyanosis; Fever lasting up to 48 hours; This is a spontaneous report downloaded from the regulatory authority PL-URPL-3-86-2020, Sender Type: Agency, Sender''s Organisation: from a contactable Physician received from the Regulatory Authority. The Regulatory Authority report number is PL-URPL-3-86-2020. The reporter is contactable. A 3-months-old male patient received first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, lot. X63656, exp. Oct2020) via intramuscular in right thigh on 09Jan2020 13:30 at 0.5 ml, single for immunization. Medical history included Urinary tract infection, site not specified (Hospitalization 06-16.12.2019), dehydration (Hospitalization 06-16.12.2019), Enteritis due to adenovirus (Hospitalization 01-05.12.2019). Concomitant medication included ibuprofen (IBUM) from 11Jan2020 13:30, paracetamol from 11Jan2020. The patient experienced no muscle tone on 11Jan2020, respiratory arrest on 11Jan2020, crying on 11Jan2020, purulent meningitis secondary to otitis media (left ear) on unknown date, cardiac arrest on 11Jan2020, moaning on 11Jan2020, fever lasting up to 48 hours on 10Jan2020, cyanosis on 11Jan2020. The events were all fatal and event crying was also medically significant. The patient underwent lab tests and procedures which included body temperature: 38.5-38.9 degree celsius on unknown date. The patient died on 11Jan2020. It was not reported if an autopsy was performed. SENDER COMMENT: Fever and crying are the expected adverse reactions listed in point 4.8. Summary of Product Characteristics for Prevenar 13. Continuous crying is not mentioned in section 4.8. SmPC. Until 28 January 2020 470 cases of persistent crying after the Prevenar 13 vaccine were reported in the regulatory authority database. Cyanosis, "moaning", shortness of breath, lack of heart rate and muscular tone were not mentioned in section 4.8. SmPC of Prevenar 13. Purulent meningitis is an unexpected adverse reaction not mentioned in section 4.8. Summary of Product Characteristics of Prevenar 13. ''In most cases caused by Neisseria meningitidis, Streptococcus pneumoniae or Haemophilus influenzae b, and in older children by N. meningitidis, S.pneumoniae and in special circumstances by other bacteria (...) or by other pathogens in children in states of immunosuppression. The disease begins suddenly with fever, vomiting and anxiety; emboli emphysema eruptions occur on the skin in meningococcal septicemia (...). Mortality from purulent meningitis is 20% in newborns and up to 10% in infants. Until 6 February 2020 70 cases of meningitis after vaccination with Prevenar 13 were reported in the regulatory authority database, including fatalities. Due to the lack of detailed information on the etiology of purulent meningitis, Prevenar 13 cannot be clearly identified as responsible for the occurrence of adverse reactions. Due to the hospitalization of the child twice for infectious reasons and his prematurity, it cannot be excluded that the reason for the above symptoms could be a factor other than the vaccine. If additional information is obtained, a follow-up will be performed. The person reporting unexpected post vaccination reaction qualified it as serious (death). Due to the patient''s death, the nature of adverse reactions (continuous crying) and the assessment of the reporting person (serious), regulatory authority classified unexpected post vaccination reaction as serious. Prevenar 13: Other Assessment: Agency,WHO,Possible. No follow-up attempts needed. No further information expected.; Reported Cause(s) of Death: No muscle tone; Respiratory arrest; Crying; Cardiac arrest; Moaning; Fever lasting up to 48 hours; Cyanosis; Purulent meningitis secondary to otitis media (left ear); purulent meningitis secondary to otitis media (left ear)


VAERS ID: 863079 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2011-01-04
Onset:2011-01-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Multiple organ dysfunction syndrome, Product quality issue, Pyrexia, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRGLAXOSMITHKLINEKR2020AP

Write-up: MULTIPLE ORGAN FAILURE; DRUG QUALITY PROBLEM; CONVULSION; FEVER; This case was reported by a consumer via regulatory authority and described the occurrence of convulsion in a 1-year-old female patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included Polio Trivalent Inactivated (Poliomyelitis vaccine inactivated) for prophylaxis. On 4th January 2011, the patient received Infanrix and Poliomyelitis vaccine inactivated. On 4th January 2011, less than a day after receiving Infanrix and Poliomyelitis vaccine inactivated, the patient experienced convulsion (serious criteria death and GSK medically significant) and fever (serious criteria death). On an unknown date, the patient experienced multi-organ failure (serious criteria death and GSK medically significant) and product quality issue. On an unknown date, the outcome of the convulsion, fever and multi-organ failure were fatal and the outcome of the product quality issue was unknown. The reported cause of death was convulsion, fever and multi-organ failure. It was unknown if the reporter considered the convulsion, fever and multi-organ failure to be related to Infanrix and Poliomyelitis vaccine inactivated. Additional details were received as follows: Agency has been made aware of this case on 8th February 2011. The age at vaccination was not reported. Less than 2 months after vaccination, the patient experienced multiple organ failure.; Reported Cause(s) of Death: Convulsion; Fever; Multi-organ failure


VAERS ID: 863123 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-01-04
Onset:2011-01-01
Submitted: 0000-00-00
Entered: 2020-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Multiple organ dysfunction syndrome, Product quality issue, Pyrexia, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRGLAXOSMITHKLINEKR2020AP

Write-up: CONVULSIONS; fever; MULTIPLE ORGAN FAILURE,; DRUG QUALITY PROBLEM; This case was reported by a consumer via regulatory authority and described the occurrence of convulsion in a female patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included Polio Trivalent Inactivated (Poliomyelitis vaccine inactivated) for prophylaxis. On 4th January 2011, the patient received Infanrix and Poliomyelitis vaccine inactivated. On 4th January 2011, less than a day after receiving Infanrix and Poliomyelitis vaccine inactivated, the patient experienced convulsion (serious criteria death, hospitalization and GSK medically significant) and fever (serious criteria death and hospitalization). In January 2011, the patient experienced multi-organ failure (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the patient experienced product quality issue. On an unknown date, the outcome of the convulsion, fever and multi-organ failure were fatal and the outcome of the product quality issue was unknown. The reported cause of death was convulsion, fever and multi-organ failure. It was unknown if the reporter considered the convulsion, fever and multi-organ failure to be related to Infanrix and Poliomyelitis vaccine inactivated. Additional details were received as follows: Authority has been made aware of this case on 26th January 2011. The age at vaccination was not reported. The reported event drug quality complaint has been coded with product quality complaint as per available coding.; Reported Cause(s) of Death: Convulsion; Fever; Multi-organ failure


VAERS ID: 863126 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-01-04
Onset:2011-01-01
Submitted: 0000-00-00
Entered: 2020-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Encephalopathy, Hyperthermia, Myocarditis
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Accidents and injuries (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRGLAXOSMITHKLINEKR2020AP

Write-up: Hyperthermia; Myocarditis; Encephalopathy; This case was reported by a non-health professional via regulatory authority and described the occurrence of encephalopathy in a 5-year-old female patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included Polio Trivalent Inactivated (Poliomyelitis vaccine inactivated) for prophylaxis. On 4th January 2011, the patient received Infanrix and Poliomyelitis vaccine inactivated. On 4th January 2011, less than a day after receiving Infanrix and Poliomyelitis vaccine inactivated, the patient experienced hyperthermia (serious criteria death and hospitalization). In January 2011, the patient experienced encephalopathy (serious criteria death, hospitalization and GSK medically significant) and myocarditis (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the encephalopathy, hyperthermia and myocarditis were fatal. The reported cause of death was encephalopathy, hyperthermia and myocarditis. It was unknown if the reporter considered the encephalopathy, hyperthermia and myocarditis to be related to Infanrix and Poliomyelitis vaccine inactivated. Additional details were received as follows: Agency has been made aware of this case on 13th January 2011. The age at vaccination was not reported. This report was received from regulatory authority and it was reported as literature to the authority.; Reported Cause(s) of Death: Encephalopathy; Hyperthermia; Myocarditis


VAERS ID: 863250 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2009-03-17
Onset:2009-03-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2020-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRGLAXOSMITHKLINEKR2020AP

Write-up: Death; This case was reported by a consumer via regulatory authority and described the occurrence of unknown cause of death in a 1-year-old male patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis and Polio Trivalent Inactivated (Poliomyelitis vaccine inactivated) for prophylaxis. On 17th March 2009, the patient received Infanrix, Hepatitis B vaccine and Poliomyelitis vaccine inactivated. On 19th March 2009, 2 days after receiving Infanrix, Hepatitis B vaccine and Poliomyelitis vaccine inactivated, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Infanrix, Hepatitis B vaccine and Poliomyelitis vaccine inactivated. Additional details were received as follows: Agency has been made aware of this case on 27th March 2009. The age at vaccination was not reported. Suspects have been coded per GSK coding conventions.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 863378 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time prolonged, Alanine aminotransferase increased, Antimicrobial susceptibility test sensitive, Anuria, Aspartate aminotransferase increased, Autopsy, Bacterial test, Blood albumin decreased, Blood creatine phosphokinase increased, Blood creatinine increased, Blood fibrinogen decreased, Blood glucose normal, Blood lactate dehydrogenase increased, Blood potassium normal, Blood sodium normal, Blood test, Blood urea increased, C-reactive protein increased, Chest X-ray normal, Coagulation test abnormal, Coagulation time prolonged, Complement factor, Cough, Cyanosis, Death, Echocardiogram, Endotracheal intubation, Fibrin degradation products increased, Glycosylated haemoglobin increased, Haematocrit normal, Haemoglobin normal, Immunology test, Liver function test abnormal, Lymphocyte percentage decreased, Neutrophil percentage increased, Neutrophilia, Oedema peripheral, Organ failure, Platelet count decreased, Pneumococcal sepsis, Protein total decreased, Prothrombin time prolonged, Renal function test abnormal, Streptococcus test positive, Ultrasound abdomen normal, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Hospitalisation; Pneumococcal sepsis
Preexisting Conditions: Medical History/Concurrent Conditions: Anuria; Asplenia (mother); Asplenia; Congenital hepatitis B infection; Cough; Cyanosis; Edema limbs; Hypospadias; Pneumococcal sepsis
Allergies:
Diagnostic Lab Data: Test Name: Ultrasound abdomen; Result Unstructured Data: Test Result: normal spleen and no evidence of any immunodeficie; Comments: Respiratory rate (Unknown date): of 40 /rnin. Heart rate (Unknown date): of 144 beats/min. Oxygen saturation (Unknown date):82% with oxygen 5 L/min. splenic morphology (Unknown date):normal spleen and no evidence of any immunodeficiency disorder. antibiotic sensitivity tests (Unknown date):revealed that both sets of isolates had a similar antibiotic sensitivity profiie Oxygen (Unknown date): 5 L/min. ultrasound (Unknown date):normal spleen and no evidence of any immunodeficiency disorder. white blood cell count (Unknown date): normal. organ function (Unknown date): deteriorated. Laboratory test results (Unknown date): revealed a neutrophilia with normal white blood cell count (6400 cells/uL, with 90.2% neutrophiis}, and a platelet count of 34000 ceIls/uL. Platelets (Unknown date): Recorded value- 3.4 x 10^4/uL, Standard value- (14.8-33.9) X 10^4/uL. CLDM sensitivity testing (Unknown date): 0.12 g/ml. ABPC (Ampicillin) sensitivity testing (Unknown date): CDC Split Type: JPPFIZER INC2020070445

Write-up: S. pneumoniae was isolated/pneumococcal sepsis/In spite of rapid initiation of antimicrobial therapy. catecholaminergic therapy. fluid resuscitation, and intubation, the patient''s organ function deter; S. pneumoniae was isolated/pneumococcal sepsis/In spite of rapid initiation of antimicrobial therapy. catecholaminergic therapy. fluid resuscitation, and intubation, the patient''s organ function deter; This is a literature report. Through this report authors aim to make readers aware of the familial nature of some asplenism and of the need to screen family members of individuals with congenital asplenism. Case presentation: Chief complaints: Case 1: Patient 1, a 38-year-old male with a medical history of congenital hepatitis B infection and hypospadias was brought to authors'' emergency department complaining of cyanosis, cough, and edema of his limbs. History of past illness: Case 1: The patient had a medical history of congenital hepatitis B infection and hypospadias. Personal and family history: Case 1: His family history contained nothing of note; specifically, there was no family history of any immunodeficiency disorder or other congenital anomalies. Physical examination upon admission: Case 1: His vital signs were markedly abnormal with a respiratory rate of 40 /min, body temperature at 35.9 degree C, a heart rate of 144 beat/min, and oxygen saturation at 82% with oxygen 5 L/min. His blood pressure was 52/38 mmHg. He was oriented in time, place and person. On physical examination he was found to have cyanosis of the limbs. Laboratory examinations: Case 1: Laboratory test results revealed a neutrophilia with normal white blood cell count (6400 cells/uL, with 90.2% neutrophils}, and a platelet count of 34000 ceIls/uL. Liver and kidney function test results were grossly abnormal, and coagulation times were severely prolonged. The results of the bleed test taken at this stage are presented in Table 1. A urinary sample could not be obtained because the patient had anuria. Imaging examinations: Case 1: His chest X-ray was unremarkable. Final diagnosis: He was clinically diagnosed as having overwhelming pneumococcal sepsis secondary to hyposplenia. Treatment: Case 1 In spite of rapid initiation of antimicrobial therapy. catecholaminergic therapy. fluid resuscitation, and intubation, the patient''s organ function deteriorated and he died two hours after admission. Outcome and follow-up: Case 1 An autopsy revealed that he had an extremely small spleen (Small spleen In patient 1. Autopsy indicated an extremely small spleen with a weight of 30 g.), and S. pneumoniae was isolated from his blood, muscles, lungs, and spleen on culture. Although bacterial strain analysis did not match with the samples from both patients, antibiotic sensitivity tests revealed that both sets of isolates had a similar antibiotic sensitivity profile. Results of antibiotic sensitivity testing (g/mL): Strain: Patient 1: penicillin G: less than and equal to 0.06, Ampicillin: less than and equal to 0.12, Ceftriaxone: less than and equal to 0.06, Cefepime: less than and equal to 0.06, cefaclor: less than and equal to 0.5, Meropenem: less than and equal to 0.015, clarithromycin: 1, Azithromycin: more than 4, clindamycin: 0.12, vancomycin: 0.25, Levofloxacin: 1. After encountering these two familial cases. Authors examined the child of the Patient 1 to assess whether he had any immune system abnormalities. According to the echocardiogram, abdominal ultrasound including splenic morphology, and blood examination with immunoglobulin and complement, the child had a normal spleen and no evidence of any immunodeficiency disorder. Since he had received only the heptavalent pneumococcal vaccine, authors gave him an additional 13-Valent vaccine to prevent recurrence of the infection identified in Patients 1 and 2. Discussion: Authors encountered two first-degree relatives with septic shock caused by S. pneumoniae. To the best of authors'' knowledge this is the first report of possible household transmission of S. pneumoniae infection among family members with congenital hyposplenia/asplenia. Moreover, there has only been one previous report of S. pneumoniae bacteremia acquired by household transmission. The two cases presented in authors'' report provide the following lessons: (1) S. pneumonia infection may be transmitted within a household, so other household members should be warned it another person in the household develops a S. pneumonia infection; and (2) Asplenia/hyposplenia is sometimes congenital, so the family members of patients found to have asplenia/hyposplenia should be screened for these conditions. Authors'' two patients had no evidence of acquired asplenia or hyposplenism, and are likely to have had congenital asplenia/hyposplenia. Encapsulated bacteria are particularly resistant to phagocytosis and frequently cause severe infection in patients with impaired splenic function. The clinical symptoms of S. pneumoniae infection in patients with impaired splenic function can be nonspecific, but purpura fulminans, as occurred in Patient 1 in the Current report, appears to be more common in asplenic patients with pneumococcal infections. Immediate empiric antibiotic administration and aggressive supportive care are essential for the management of sepsis in patients with impaired splenic function because progression to septic shock can be rapid. In authors'' case, it is likely that the bacteria were transmitted from Patient 1 to Patient 2 and that she became a carrier before developing symptoms because of her asplenia. Patient 2 may also have become infected via a child, who was a carrier and was living with the family. Given that authors'' two patients had no other abnormalities, ICA, a rare condition in which affected individuals are missing their spleen but have no other developmental abnormalities, is the most likely diagnosis. The incidence of ICA is unclear because no comprehensive surveys have been performed; to authors'' knowledge, the only such report estimated the frequency of ICA in the population to be 0.51 per million births. Although most individuals with ICA have no spleen at all, some people have a very small, nonfunctional spleen, such as that of Patient 1. ICA differs from asplenia that is associated with other complex visceral defects, as it is caused by a gene mutation that affects the production of ribosomal protein SA (RPSA). The mutation occurs on the short arm of chromosome 3 at position 22.1. RPSA gene mutations are thought to reduce the amount of functional RPSA and expression of key spleen patterning genes. The RPSA gene is inherited in an autosomal dominant pattern. However, since some of the mutations have incomplete penetrance, authors were unable to determine whether the children of Patient 1 had not inherited the faulty gene, or had inherited the gene, but were unaffected due to incomplete penetrance. Authors assume the difference of splenic expression between Patients 1 and 2 was due to variable penetrance. Of two patients in this report, authors should have suspected that Patient 1 had congenital asplenia after discovering that he had hyposplenia on biopsy. Other members of his family should have been screened members and educated about their possible vulnerability to pneumococcal infections. Conclusion: in conclusion, authors encountered a case of septic shock syndrome associated with pneumococcal bacteremia in a man with hyposplenia and a similar case in his mother who had asplenia. Pneumococcal bacteremia caused by virulent S. pneumoniae may be transmitted within a household. and educating family members is essential. When individuals are diagnosed as having congenital asplenia/hyposplenia, other family members should be screened. Laboratory data of Patient 1 upon admission: white blood cell count: 6400/ul (Standard value, SV: 3590-9640/uL), neutrophils: 90.2%, (SV: 41.2%-74.7%), lymphocytes: 8.4% (SV: 21.2% -51.0%), hemoglobin: 16.1 g/dL, (SV: 13.2 - 17.2 g/dL), hematocrit: 47.3% (SV: 40.4% - 51.1%), platelets: 3.4X10^4/uL (SV: (14.8-33.9) x10^4/Ul), C-reactive protein: 18.2 mg/dL (SV: less than and equal to 0.30 mg/dL), total protein: 5.5 g/dL (SV: 6.7-8.3 g/dL), albumin: 2.9 g/dL, (SV: 3.9-4.9 g/dL), aspartate aminotransferase: 232 U/L, (SV: 13-33 U/L), alanine aminotransferase: 154 U/ L (SV: 6-30 U/ L), lactate dehydrogenase: 700 U/L, (SV: 119-229 U/ L), creatine phosphokinase: 356 U/L, (SV: 62-287U/ L), blood nitrogen urea: 35 mg/dL (SV: 8-22 mg/dL), creatinine: 4.72 mg/dL (SV: 0.60-1.10 mg/dL), sodium: 136 mEq/L (SV: 138-146 mEq/L), potassium: 4.4 mEq/L (SV: 3.6-4.9 mEq/ L), glucose: 118 mg/dL (SV: 60-160 mg/dL), hemoglobin A1c: 6.7% (SV: 4.6% - 6.2%), prothrombin time: 24.8 s (SV: 9.4 -12.5 s), activated partial thromboplastin time: 97.8 s (SV: 25.1 - 36.5 s), fibrinogen: 131 mg/dl (SV: 155-415 mg/dL), fibrin/fibrinogen degradation products: 68.6 ug/mL (SV: 0 - 4.9 ug/mL). Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (Dipht CRM197 Protein) and pneumococcal 7-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (Dipht CRM197 Protein) and pneumococcal 7-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.; Reported Cause(s) of Death: pneumococcal sepsis; the patient''s organ function deteriorated and he died two hours after admission; In spite of rapid initiation of antimicrobial therapy. catecholaminergic therapy. fluid resuscitation, and intubation, the patient''s organ function ; Autopsy-determined Cause(s) of Death: S. pneumoniae was isolated


VAERS ID: 863826 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2011-01-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Multiple organ dysfunction syndrome, Product quality issue
SMQs:, 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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRGLAXOSMITHKLINEKR2020AP

Write-up: Multiple organ failure; DRUG QUALITY PROBLEM; This case was reported by a consumer (reporter was reported as other HCP) via regulatory authority and described the occurrence of multi-organ failure in a 1-year-old female patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included Polio Trivalent Inactivated (Poliomyelitis vaccine inactivated) for prophylaxis. On 4th January 2011, the patient received Infanrix and Poliomyelitis vaccine inactivated. On an unknown date, unknown after receiving Infanrix and Poliomyelitis vaccine inactivated, the patient experienced multi-organ failure (serious criteria death, GSK medically significant and other: Serious per reporter) and product quality issue. On an unknown date, the outcome of the multi-organ failure was fatal and the outcome of the product quality issue was unknown. The reported cause of death was multi-organ failure. It was unknown if the reporter considered the multi-organ failure and product quality issue to be related to Infanrix and Poliomyelitis vaccine inactivated. Additional details were provided as follows: Agency has been made aware of this case in 2011. The age at vaccination was not reported.; Reported Cause(s) of Death: Multi-organ failure


VAERS ID: 864208 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-28
Onset:2019-12-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2020-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Antibody test negative, Death, Influenza, Pneumococcal infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (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:
Current Illness: Prophylactic vaccination
Preexisting Conditions: Medical History/Concurrent Conditions: Decreased immune responsiveness; Poliomyelitis; Comments: Previous Polio patient.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DK0095075132002DNK010698

Write-up: Pneumococcal infection; Influenza; patient developed influenza despite the influenza vaccine; Every second year throughout many years, antibodies were measured following pneumococcal vaccination, and antibodies were very low already 24 months after the vaccinations; This spontaneous report was received from a general practitioner via an sales representative referring to a 67-year-old female patient. The patient''s medical histories included polio and poor response to vaccines. In 2018, the patient was vaccinated with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVENAR). Concurrent condition was not reported. Every second year throughout many years, antibodies were measured following pneumococcal vaccination, and antibodies were very low already 24 months after the vaccinations (antibody test negative). The patient therefore received frequent pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) re-vaccinations since the patient was a high-risk patient. On 28-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) (strength, dose, route, lot #, expiration date and anatomical location were not reported) for prophylaxis. On the same date, the patient was vaccinated with influenza virus vaccine (unspecified) (strength, dose, route, lot #, expiration date and anatomical location were not reported) for prophylactic vaccination. In late December 2019, the patient developed influenza despite influenza virus vaccine (unspecified). The patient was hospitalized due to the influenza and there was a fatal outcome, and the date of death was unknown. At the hospital, a pneumococcal infection was also diagnosed. The outcome of influenza, pneumococcal infection and vaccination failure was fatal. The outcome of antibodies were very low was unknown. If an autopsy was performed and cause of death were unknown. The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) and the events was unknown. Upon internal review, pneumococcal infection was determined to be medically significant.


VAERS ID: 864267 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-02-21
Onset:2020-02-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B331AI / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Exposure during pregnancy, Foetal death
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITGLAXOSMITHKLINEIT202003

Write-up: Fetal exposure during pregnancy; Intrauterine death; This retrospective pregnancy case was reported by a physician via call center representative and described the occurrence of intra-uterine death in a patient exposed to DTPa (Reduced antigen) (Boostrix) (batch number AC37B331AI, expiry date unknown) in utero. The mother received the product for prophylaxis. The parent''s medical history included anemia and hypothyroidism. On 21st February 2020, the 20-year-old mother received Boostrix. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient was exposed to Boostrix at an unknown time during the pregnancy. The patient was diagnosed with intra-uterine death (serious criteria death and GSK medically significant). On an unknown date, the patient experienced fetal exposure during pregnancy. On an unknown date, the outcome of the intra-uterine death was fatal and the outcome of the fetal exposure during pregnancy was unknown. It was unknown if the reporter considered the intra-uterine death to be related to Boostrix. Additional details were provided as follows: The patient received Boostrix by transplacental route. The reporter stated that, after vaccination, the patient experienced intra-uterine death and fetal exposure during pregnancy.


VAERS ID: 864315 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-10-02
Onset:2019-11-15
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2020-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 259141B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood blister, Brain death, C-reactive protein increased, Circulatory collapse, Computerised tomogram head abnormal, Death, Haemoglobin normal, Immune thrombocytopenia, Intensive care, Life support, Neutrophil count decreased, Platelet count normal, Subarachnoid haemorrhage, White blood cell count normal
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-18
   Days after onset: 3
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: IRON
Current Illness: Anaemia; Renal stone
Preexisting Conditions: Medical History/Concurrent Conditions: Hip replacement; Lithotripsy; Pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 20191117; Test Name: CT scan of head; Result Unstructured Data: A fatal subarachnoid haemorrhage was identified.; Test Date: 20191117; Test Name: PLT
CDC Split Type: GBSEQIRUS202002300

Write-up: Fatal subarachnoid haemorrhage; Collapsed; ITP (Immuno thrombocytopenic purpura); This is a spontaneous case from, reported by other non-health professional to agency (reference number: 2020-0040501) on 03-Mar-2020, concerning a 70-year-old, male patient. The patient''s relevant medical history included recent lithotripsy for recurrent renal stones, mild anaemia, hip replacement in Aug-2019 and pneumonia in 2017. The patient''s concomitant medication included unspecified iron supplements for mild anaemia. On 02-Sep-2019, the patient''s haemoglobin (Hb) was at 103, white blood cell (WBC) count was at 4.4, neutrophils (N) were at 1.84, platelet (Plt) count was at 236 and C-reactive protein (CRP) was at 15.3. The units were not specified. There was concern over a suspected lower respiratory tract infection and subsequent suspicion of a pulmonary embolism, but both were ruled out. On 17-Sep-2019, the patient''s Hb was at 103, WBC count was at 5.2, N were at 2.88, Plt count was at 187 and CRP was at 21. The units were not specified. On 02-Oct-2019, the patient was administered Fluad (TIV) vaccine [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; batch number: 259141B1A, expiration date: 31-May-2020, dose, route of administration and anatomical location: not reported] for an unknown indication. On 31-Oct-2019, the patient''s Hb was at 125, WBC count was at 5.4, N were at 3.28 and Plt count was at 213. The units were not specified. On 15-Nov-2019, on Friday, the patient developed blood filled blisters for which he sought medical attention. On 16-Nov-2019, on Saturday, the patient developed a purpura to his back. It was reported that at this point in time the patient otherwise did not feel unwell. On 17-Nov-2019, on Sunday morning, the patient collapsed at home and was taken to the hospital. A computed tomography (CT) scan of his head identified a fatal subarachnoid haemorrhage. The blood test results revealed a Plt count of 6, Hb was at 127, WBC was at 8.2, N were at 5.07 and CRP was at 18.9. The patient was diagnosed with immune thrombocytopenic purpura (ITP) and placed on organ support on the intensive care unit (ICU). On 18-Nov-2019, 24 hours after being placed on organ support, brainstem death was confirmed and the patient passed away. At the time of this report, the outcome for the events of ITP and circulatory collapse was not reported. The event of ?subarachnoid haemorrhage'' was considered as serious due to criterion of death, hospitalisation and medical significance, while the events of ?immune thrombocytopenic purpura'' and ?circulatory collapse'' were considered as serious due criterion of hospitalisation and medical significance, per company. The reporter stated that she believed there was a reasonable possibility that the flu vaccine may had caused the acute underlying ITP. The reporter did not provide causality assessment for the event of ?subarachnoid haemorrhage'' and ?circulatory collapse''. Company comment: The patient experienced immune thrombocytopenic purpura (ITP) one month and 13 days after receiving Fluad (TIV) vaccine. The patient also collapsed, developed subarachnoid haemorrhage and eventually died. Chronology is plausible. Causal role of the vaccine is assessed as possibly related for ITP, since research showed that influenza vaccinations increase the risk of ITP. Although circulatory collapse and subarachnoid haemorrhage were likely attributed to ITP, patient advanced age (70) may have contributed to development of the events, causality is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes).; Sender''s Comments: The patient experienced immune thrombocytopenic purpura (ITP) one month and 13 days after receiving Fluad (TIV) vaccine. The patient also collapsed, developed subarachnoid haemorrhage and eventually died. Chronology is plausible. Causal role of the vaccine is assessed as possibly related for ITP, since research showed that influenza vaccinations increase the risk of ITP. Although circulatory collapse and subarachnoid haemorrhage were likely attributed to ITP, patient advanced age (70) may have contributed to development of the events, causality is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes).; Reported Cause(s) of Death: Fatal subarachnoid haemorrhage


VAERS ID: 864395 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Infertility, Premature menopause
SMQs:, Fertility disorders (narrow), 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CH0095075132003CHE002445

Write-up: Gardasil has been associated with numerous deaths and over 8000 adverse reactions; 8000 adverse reactions; Gardasil is now said to adversely affect ovarian function; woman in question become infertile; This spontaneous report has been received from an unspecified reporter via a company representative from an online article referring to an unspecified number of patients of unknown age and gender. Information regarding the patient''s medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided. On an unknown date, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (indication, strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date, numerous deaths were associated with vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). Over 8000 adverse reaction and unspecified number of dramatic side effects were were associated with vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). It was mentioned that quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) affect ovarian function and that can cause female patients to experienced adverse events that had not been expected, in addition it was also stated that might be a connection between vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and a very severe premature ovarian failure which was further described as premature menopause where the ovaries stop working, no more oocytes mature and where the woman in question becomes infertile. According to the article, since 2006, 213 reports were published regarding amenorrhea and ovarian failure and that 88% of these were linked to vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). The outcome of death was reported as fatal. The outcome of adverse reaction, infertility and ovarian failure was unknown.


VAERS ID: 864459 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Autopsy, Blood bilirubin increased, Blood bilirubin unconjugated increased, Chromaturia, Death, Faeces pale, Haemorrhagic disorder, Hepatic necrosis, Hepatitis A virus test, Hepatitis B, Hepatitis B core antibody positive, Hepatitis B core antigen positive, Hepatitis B e antigen positive, Hepatitis B surface antigen positive, Hepatitis C test negative, Hepatitis D virus test, Hepatitis viral test negative, Hepatomegaly, Immunology test, Jaundice, Multiple organ dysfunction syndrome, Ocular icterus, Polymerase chain reaction positive, Vertical infection transmission
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver infections (narrow), Acute pancreatitis (narrow), Haemorrhage terms (excl laboratory terms) (narrow), 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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Cardiomyopathy (broad), Conjunctival disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic hepatitis B (to mother)
Allergies:
Diagnostic Lab Data: Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result: 2320, Test Result Unit: u/L; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result: 3117, Test Result Unit: u/L; Test Name: Bilirubin total; Result Unstructured Data: Test Result: 226 (direct: 88, indirect: 138), Test Result Unit: umol/L; Test Name: Hepatitis A IgM; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: Hepatitis A virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: Hepatitis B core antibody; Result Unstructured Data: Test Result: positive, Test Result Unit: unknown; Test Name: Hepatitis B core antibody; Result Unstructured Data: Test Result: positive, Test Result Unit: unknown; Test Name: HBV DNA detectable; Result Unstructured Data: Test Result: 1.6 x 10e5 (positive Hepatitis B), Test Result Unit: iu/ml; Test Name: HBeAG; Result Unstructured Data: Test Result: positive, Test Result Unit: unknown; Test Name: HBsAg; Result Unstructured Data: Test Result: positive, Test Result Unit: unknown; Test Name: Hepatitis C antibody; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: Hepatitis C virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: Hepatitis D antibody; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: Hepatitis D virus test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Name: Enzyme-linked immunosorbent assay; Result Unstructured Data: Test Result: positive Hepatitis B, Test Result Unit: unknown; Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: positive Hepatitis B, Test Result Unit: unknown
CDC Split Type: RUGLAXOSMITHKLINERU2020EM

Write-up: Multiple organ failure; liver necrosis; jaundice/ icteric skin; Hepatomegaly; Icteric sclera; Acholic stool; Dark urine; Hemorrhagic syndrome; Hepatitis B virus infection; Vertical infection transmission; This case was reported in a literature article and described the occurrence of multi-organ failure in a 3-month-old female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included BCG VACCINE (BACILLUS CALMETTE-GUERIN VACCINE) for prophylaxis. The patient had a Family History of chronic hepatitis b (to mother). On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and BACILLUS CALMETTE-GUERIN VACCINE at an unknown dose. On an unknown date, 1 month after receiving Hepatitis B vaccine and an unknown time after starting lamivudine, the patient experienced multi-organ failure (serious criteria death, hospitalization and GSK medically significant), hepatic necrosis (serious criteria death, hospitalization and GSK medically significant), jaundice (serious criteria hospitalization), hepatomegaly (serious criteria hospitalization), scleral icterus (serious criteria hospitalization), acholic stool (serious criteria hospitalization), urine discoloration (serious criteria hospitalization), hemorrhagic disorder (serious criteria hospitalization and GSK medically significant), hepatitis b (serious criteria hospitalization and GSK medically significant) and vertical infection transmission. The patient was treated with lamivudine, ceftriaxone, interferon alfa-2b (Viferon) and corticosteroid nos (Corticosteroids Nos). On an unknown date, the outcome of the multi-organ failure and hepatic necrosis were fatal and the outcome of the jaundice, hepatomegaly, scleral icterus, acholic stool, urine discoloration, hemorrhagic disorder, hepatitis b and vertical infection transmission were unknown. The reported cause of death was multi-organ failure and hepatic necrosis. An autopsy was performed. It was unknown if the reporter considered the multi-organ failure, hepatic necrosis, jaundice, hepatomegaly, scleral icterus, acholic stool, urine discoloration, hemorrhagic disorder, hepatitis b and vertical infection transmission to be related to Hepatitis B vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of hepatitis B virus infection (severe form) in a 3-month-old female patient who was vaccinated with unspecified Hepatitis B virus (HBV) vaccine for prophylaxis. The patient was born to a mother with chronic hepatitis B. The first detected viral load before childbirth in the patient''s mother was 500 copies of HBV DNA/mL, surface antigen of the hepatitis B virus (HBsAg) was positive (+), hepatitis B e-antigen (HBeAg) was negative (-). The patient was one twins. The height of the patient was 42 cm at birth, while the weight was 2100 g. Given the severity of the hypoxic damage of the central nervous system (CNS), the patient was not vaccinated in the hospital. No information on patient''s concomitant medication or concurrent condition was provided. On an unspecified date, at the age of 2 months, the patient received unspecified Hepatitis B virus (HBV) vaccine and Bacillus Calmette-Guerin vaccine (administration route and site unspecified, dosage unknown; batch number not provided for both). On an unspecified date, at the age of 3 months, 1 month after the vaccination, the disease emerged when the patient''s mother noticed jaundice. On the second day of the disease, the patient was hospitalized in a moderately severe condition; icteric skin and sclera, hepatomegaly up to 1.5 cm below the costal margin, acholic stool and dark urine were observed. Laboratory tests showed: alanine aminotransferase (ALT): 2320 U/L, aspartate aminotransferase (AST): 3117 U/L, total bilirubin: 226 ?mol/L (direct: 88, indirect: 138). Serological examination by enzyme-linked immunosorbent assay (ELISA) revealed the following: HBsAg was positive, IgM antibody to hepatitis B core antigen (anti-HBc IgM) was positive, HBeAg was positive, anti-HB core (total) was positive. HBV DNA by polymerase chain reaction (PCR) method was positive, 1.6 x 10e5 IU/mL. Hepatitis A, C, D markers was negative: anti-HCV was negative, anti-HAV IgM was negative, anti-Delta IgM was negative, anti-Delta IgG was negative. The following diagnosis was established: Hepatitis B, severe form. Basic therapy with VIFERON, rectal suppositories at a dose of 150,000 IU twice a day was prescribed. However, the condition of the patient progressively worsened with the development of liver necrosis and an increase in the manifestations of hemorrhagic syndrome. Subsequently, corticosteroids, Lamivudine and Ceftriaxone were added to the basic syndromic therapy. On an unspecified date, despite the ongoing therapy, a month after the onset of the disease, the patient died with underlying multiple organ failure. On an unspecified date, autopsy was performed which revealed massive necrosis of the liver. This case has been considered serious due to death and hospitalization. The author concluded, "Recently, we have been observing the development of fulminant forms of hepatitis B with the perinatal way of infection. The cause of this disease was the lack of hepatitis B vaccination for a child at risk (mother with chronic hepatitis B). From the first days of the disease, the child had symptoms of hepatic cell failure, but without neurological symptoms, which are usually present in the malignant form of HBV. Antiviral and hormonal therapy did not improve the prognosis of the disease. It is important to observe the hepatitis B vaccination schedule in children at risk." This article corresponding to this case is not available for regulatory submission due to copyright restriction. Lab Comments: Lab test done on an unknown date.; Reported Cause(s) of Death: Multi-organ failure; liver necrosis


VAERS ID: 864498 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-02-29
Onset:2020-03-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Cyanosis, Death, Erythema, Gaze palsy, Haematocrit decreased, Inflammation, Jaundice, Myoclonic epilepsy, Respiratory arrest, Seizure, Stupor
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LB0095075132003LBN001197

Write-up: CONVULSION; Stupor Cyanosis/blueish; Stupor Cyanosis/blueish; DEATH; REPIRATORY ARREST; Myoclonic status seizure; he had a red cheek on one side only; Possible inflammation; Prolonged jaundice; This spontaneous report was received from a healthcare professional regarding a 2 month old male patient. The patient''s medical history, concurrent conditions and concomitant therapies were not reported. On 29-FEB-2020 (reported as ''two days prior''), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ VACCINE, LIVE ORAL PENTAVALENT) via oral route (strength, dose, anatomical location, lot and expiry dates were not reported) for prophylaxis. On 01-MAR-2020 (reported as ''day before admission''), the child was close to heater where he had a red check on one side only and a possible inflammation (erythema and inflammation). On 02-MAR-2020, according to the mother''s explanation the temperature of the patient was reported as 36.6, peripheral capillary oxygen saturation (Spo2) was 85, heart rate was 140 and fixated eyes were observed. The patient''s mother explained that the child was normal at 04:00 a.m. where the patient was fed. Then at 08:00 a.m., the mother saw the patient in that condition (reported as ''seizure and blueish'') where she fed him again (cyanosis and myoclonic epilepsy). On the same day at 11:30 a.m., the patient was admitted to the emergency room. On the same day after admission, the patient underwent blood tests results showed hematocrit (HCT) was 25 with a prolonged jaundice and the patient didn''t do any screening test after being born. He was given IV NaCl, D10 and phenytoin (EPANUTIN). After treatment the patient opened his eyes and myoclonic epilepsy was decreased. The patient was transferred to a hospital, where he had another convulsion (epilepsy) and respiratory arrest and the patient died due to unknown reason. It was unknown if autopsy was performed. The outcome of respiratory arrest, seizure, inflammation, erythema, jaundice, stupor, and cyanosis were unknown. Upon internal review, the events respiratory arrest, myoclonic epilepsy and seizure were determined to be medically significant.


VAERS ID: 864586 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. - / UNK - / OT
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Respiratory failure
SMQs:, Anaphylactic reaction (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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (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: Medical History/Concurrent Conditions: Anamnestic reaction
Allergies:
Diagnostic Lab Data:
CDC Split Type: UASA2020SA060615

Write-up: patient died of respiratory failure; Initial information received on 06-Mar-2020 regarding an unsolicited valid serious social media case received from a physician via Health Authorities. This case involves a six month old female patient who died of respiratory failure (respiratory failure), while she received HEPATITIS B VACCINE LG-LS [EUVAX B] and IPV (VERO) [IMOVAX POLIO]. The patient''s medical history included vaccination anamnesis (anamnestic reaction). The patient''s past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect HEPATITIS B VACCINE LG-LS and IPV (VERO) lot number and Exp. Date not reported via an unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient died of respiratory failure (respiratory failure) (unknown latency) following the administration of HEPATITIS B VACCINE LG-LS and IPV (VERO). This event was assessed as medically significant and was leading to death. Other relevant tests were not reported. Final diagnosis was (fatal) respiratory failure. It was not reported if the patient received a corrective treatment. On an unknown date, the patient died due to respiratory failure. It is unknown if an autopsy was done. The cause of death was reported as respiratory failure. Information on the batch number was requested.; Sender''s Comments: This case involves a six month old female patient who died due to respiratory failure after vaccination with EUVAX B and IMOVAX POLIO. The time to onset was unknown. However, patient''s medical history included vaccination anamnesis, her medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of the suspect vaccines cannot be assessed.; Reported Cause(s) of Death: respiratory failure


VAERS ID: 864598 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ARPFIZER INC2020103640

Write-up: The patient died; Health worsened; This is a spontaneous report from a non-contactable consumer for a patient enrolled in a Pfizer sponsored marketing program. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient''s medical history and concomitant medications were not reported. One woman reported that a relative was given the vaccine and since then her health worsened, and the patient died after applying the vaccine on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event health worsened was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities. No follow up attempts needed. No further information expected.; Reported Cause(s) of Death: The patient died


VAERS ID: 864871 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Aspiration, Death
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (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: UASA2020SA060635

Write-up: asphyxia due to the aspiration of stomach contents; asphyxia due to the aspiration of stomach contents; Initial information was received on 06-Mar-2020 regarding an unsolicited valid serious case from other health professional via the health authority. This case involves a two month old male patient who presented with asphyxia due to the aspiration of stomach contents (asphyxia) and (aspiration) and died, after he received vaccine IPV (VERO) [IMOVAX POLIO]. Medical history, past medical treatment, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect IPV (VERO) (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious asphyxia due to the aspiration of stomach contents (asphyxia) and (aspiration) (unknown latency) following the administration of IPV (VERO). These events were assessed as medically significant and was leading to death. Laboratory data was not provided. Final diagnosis was (fatal) asphyxia. 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 asphyxia and aspiration. Information on the batch number was requested.; Sender''s Comments: This case concerns a two month old male patient who died due to asphyxia following aspiration of stomach contents after vaccination with IMOVAX POLIO. The time to onset is unknown. Additional information regarding, condition at the time of vaccination, concomitant medications, lab data excluding other etiologies and detail autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: asphyxia due to the aspiration of stomach contents; asphyxia due to the aspiration of stomach contents


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: 865886 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2020-02-07
Onset:2020-02-12
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2020-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER S009985 / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Diarrhoea, Encephalitis, Loss of consciousness, Pyrexia, Seizure, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Routine childhood immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PL0095075132003POL006489

Write-up: Diarrhoea; Fever lasting up to 72 hours; Encephalitis; Convulsions - first episode; Vomiting; Loss of consciousness; Information has been downloaded from Regulatory Authority (PL-URPL-3-284-2020). This spontaneous report was received from a physician regarding a 1-year-old patient of unknown gender. The patient''s medical history, concurrent conditions and concomitant therapies were not reported. On 07-FEB-2020, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-RVAXPRO) (recombinant human albumin (rHA)) at a dose of 0.5 milliliter via intramuscular route in the right arm for routine childhood immunization (lot # S009985, expiration date reported as March 2021, but upon internal validation was established as 31-MAR-2021). On 12-FEB-2020, the patient had body temperature from 39.5 to 39.9 degree Celsius and experienced fever lasting up to 72 hours (pyrexia), diarrhoea, loss of consciousness, vomiting, convulsion (first episode) (seizure) and encephalitis. On an unknown date in February 2020, the patient was hospitalized for the reported events. On an unknown date, the patient died. The cause of death was not reported, however the outcome of diarrhoea, loss of consciousness, vomiting, seizure, encephalitis and pyrexia was reported as fatal. It was unknown if an autopsy was performed. The causality of all the reported events were considered to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-RVAXPRO).


VAERS ID: 865907 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075132003JPN002273J

Write-up: Death; Information has been received from a patient''s family concerning a male patient (age unknown) who in 2013 was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX NP) injection, parentaly (dose, lot number and expiration date were not reported) for prophylaxis. No concomitant medications were reported. In 2013, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX NP) (described above). On an unknown date, the patient died. The cause of death was unknown. Whether the autopsy was performed or not was unknown. Reporter''s comment: not provided. The reporter did not assess the relationship of death to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX NP). This is one of several reports received from the same reporter.; Sender''s Comments: JP-MSD-M2020-06566:


VAERS ID: 865936 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bordetella test positive, Cough, Death, Pertussis, Polymerase chain reaction positive
SMQs:, Anaphylactic reaction (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: Test Name: Laboratory test; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: VNGLAXOSMITHKLINEVN2020GS

Write-up: Pertussis; coughing illness; This case was reported in a literature article and described the occurrence of pertussis in a infant patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis. On an unknown date, the patient received DTP (A or W not known) at an unknown dose. On an unknown date, less than 5 months after receiving DTP (A or W not known), the patient experienced pertussis (serious criteria death, hospitalization and GSK medically significant) and cough (serious criteria death and hospitalization). On an unknown date, the outcome of the pertussis and cough were fatal. The reported cause of death was pertussis and cough. The reporter considered the pertussis and cough to be related to DTP (A or W not known). Additional details were provided as follows: This case was reported in a literature article and described the occurrence of pertussis in a patient aged between less than 2 months and less than 5 months of unspecified gender, who was vaccinated with unspecified diphtheria, pertussis and tetanus vaccine (DPT) (manufacturer unknown) for prophylaxis. The patient was a part of the cross-sectional study that aimed to evaluate effect and costs of pertussis vaccination at hospital. It was conducted this study in order to describe the current pertussis epidemiology, case management, and treatment outcome among hospitalized children under 5 years of age at this hospital from January 2015 to June 2018 with the aim to improve quality of pertussis prevention and treatment. No information on patient''s medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received 1 dose of unspecified diphtheria, pertussis and tetanus vaccine (administration route and site unspecified; batch number not provided). The age of vaccination was not provided. [This country has started mass vaccination, including DTP vaccine (diphtheria, tetanus toxoids combined with killed whole-cell pertussis) from 1985 leading to pertussis in becoming significantly reduced. Age of cases was calculated from their birthday to the date of onset of first symptom and they were separated into age groups according to the DTP vaccination schedule for children, including less than 2 months old (group has not yet received the vaccination), 2 to less than 3 months old (group would have at least 1 vaccine dose), 3 to less than 4 months old (group would have at least 2 vaccine doses), 4 to less than 5 months old (group would have at least 3 vaccine doses), 6 to less than 12 months old and 1 to less than 5 years old]. On an unspecified date between January 2015 to June 2018, an unknown period after the vaccination, the patient had coughing illness lasting 2 or more weeks, with at least one of the following signs or symptoms: paroxysms of coughing, or inspiratory whoop, or post-tussive vomiting, or apnea (with or without cyanosis). The patient was hospitalized and the diagnosis of pertussis was confirmed by positive immunoglobulin M (IgM) or polymerase chain reaction (PCR) test. The patient was more severely ill and need of oxygen (by mask over 24h) or ventilator (over 24h), or dialysis or extracorporeal membrane oxygenation (ECMO). [Pertussis cases were defined by positive laboratory tests of children under 5 years January 2015-June 2018, data on patient characteristics, clinical data and hospitalization costs were collected through patient records. Pertussis cases in the study were defined all inpatients under 5 year old that had coughing illness, with at least one of the following signs or symptoms: Paroxysms of coughing, OR Inspiratory whoop, OR post tussive vomiting, OR apnea (with or without cyanosis), AND have positive pertussis test result (IGM or PCR). Severity: All inpatients in need of oxygen (by mask over 24h) or ventilator (over 24h), or Dialysis or ECMO]. On an unspecified date, the patient was died due to pertussis. It was unknown whether the patient''s autopsy was performed or not. This case has been considered as serious due to death and hospitalization. The author commented, "Our study shows an increase in the number of patients hospitalized with pertussis as well as deaths. Most of the hospitalized cases and deaths experienced a seasonal variation with more cases in Quarter 1 and Quarter 2 each year. The prevalence of the most common complications, pneumonia, persistent cough and violent cough were significantly higher in the under-2 months group compared to the over-2 months group. The number of patients in need of oxygen and ventilator in the under 2 months age group were higher than in the group of over 2 months. The number of patients in need of dialysis or ECMO were not different between groups. The length of hospital stay and the proportion of severely ill patients in the non-vaccinated group were higher than in the vaccinated group. There are many kinds of vaccines used to prevent pertussis disease in children. The basic vaccine is the Diphtheria Pertussis and Tetanus vaccine (DPT), often used in combinations with 5 or 6 kind of vaccinate in 1 injection, these have been the most popular as Pentaxim, Hexaxim, Infanrix hexa, Tetraxim, Quinvaxem, comBE Five. Tetraxim, Pentaxim or Hexaxim vaccine are commonly used, Quinvaxen is currently not used in this country due to reported adverse effects under investigation, but is commonly used in other countries. In 2017, anti-vaccination myths based on the reported adverse effects to Quinvaxen vaccine might have influenced the vaccination rate decreased slightly (2015, 95%; 2017 97%; 2016 98%; 2018 80%), over the rate of herd immunity. However, the increase in pertussis cases occurred in 2015 and 2017 following 2 to 5 year cycles. There was also seasonal variation with most hospitalized patients and highest mortality in winter and spring, and fewer cases during autumn and fall. The hospital should be prepared to respond effectively to pertussis outbreaks in two year cycles, as well as during the winter and spring seasons. In our study, most of the infants with pertussis were less than 3 months old, accounting for more than 60%; 44% of the children were too young for the DPT vaccine. Infants less than 2 months old had the highest risk to develop pertussis infection, with a prevalence higher than in the annual report, 2015 -2018 (less than 30 %) or the percentage of pertussis cases under 1 year in some countries (40%). However, as our results are based on data from one referral hospital the incidence rate might be underestimated. Many severe clinical symptoms were found in this study, including paroxysmal respiratory distress, severe cough, pneumonia and decreased oxygen saturation, and these symptoms appeared more frequently in the less than 2 months old group similar finding as in other studies. The results highlight that vaccinations not only provide prevention from pertussis and other infections, but also decreases the direct cost of diagnosis and hospital treatment from the health insurance, hence the State budget. A more comprehensive estimate of vaccine efficacy could be obtained by evaluating some available outcome parameters including mortality, duration of hospitalization and indirect costs. There were no statistically significant differences in mortality between the two groups with and without vaccine. However, patients without vaccination had significantly longer duration of hospitalization and were more severely ill than vaccinated patients. This shows that the cost for care for non-vaccinated patients is likely to be higher for the vaccinated group. Mortality due to pertussis was all among severe cases of which were 78% were 3 months old or less. The most common source of infection for infants are their caretakers. Parents and those who have close contact with newborns are recommended by the governments in many high income countries to receive a pertussis vaccine booster dose to reduce the spread of pertussis across the population. Maternal pertussis immunization is also a possible strategy for prevention of infant pertussis infection in many countries, enabling transfer of antibodies to the fetus through the placenta as well as through breast feeding. In this study, a large proportion of hospitalized pertussis cases occurred among infants under the age for DTP vaccination. After stratifying by age and, we found that the patients acquired pertussis have more risk become severity when the patients is younger age. The rate severity is significantly highest in 2 months age group (60%) and lowest in 1 to less than 5 year old ages group (2.5%). All case deaths in this study belong sever patient group. The median of duration of hospitalization in severity group is 15 days higher 2 time than other group 8 days." The author concluded, "Incidence and proportion of complications among under two-month infants were higher than in older patients. DPT vaccination protects children from pertussis infection, and in case of pertussis infection decreases severity. Results indicate that the Ministry of Health should consider adding a booster vaccine for pregnant women in an extended vaccination program." Lab Comments: Lab test done on an unspecified date between January 2015 to June 2018, pertussis was confirmed by positive immunoglobulin M (IgM) or polymerase chain reaction (PCR) test.; Reported Cause(s) of Death: Pertussis; Cough


VAERS ID: 866291 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: B-cell lymphoma, Condition aggravated, Death, Lymphatic disorder
SMQs:, Malignant lymphomas (narrow), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Lymphatic disorder; Night sweat; Tiredness
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAGLAXOSMITHKLINECA2020AM

Write-up: Large B Cell Lymphoma; vaccine overloaded his already stressed lymphatic system and progressed aggressively; vaccine overloaded his already stressed lymphatic system and progressed aggressively; he died after two weeeks in the hospital; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included tiredness, night sweat and lymphatic disorder. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), b-cell lymphoma (serious criteria hospitalization and GSK medically significant), lymphatic disorder (serious criteria hospitalization) and condition aggravated (serious criteria hospitalization). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the b-cell lymphoma, lymphatic disorder and condition aggravated were unknown. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death, b-cell lymphoma, lymphatic disorder and condition aggravated to be possibly related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received shingrix vaccine and few months later was diagnosed with large B cell lymphoma. The patient visited the doctor prior to getting vaccine and complained about tiredness and night sweats but still doctor thought the vaccine was a good idea. The vaccine overloaded his already stressed lymphatic system and progressed aggressively. The patient died after 2 weeks in the hospital event before starting the treatment; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 866321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-03-02
Onset:2020-03-11
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2020-03-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD582A / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH CD1581 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-11
   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: Medical History/Concurrent Conditions: Hospitalization; Intubation; Mechanical ventilation; Pneumonia; Premature baby (32+1 Pregnancy week)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZERINC2020127437

Write-up: Death; This is a spontaneous report downloaded from the Regulatory Authority [regulatory authority numberDE-PEI-PEI2020001427]. A 3-month-old female patient started to receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR 13, lot number: CD1581), intramuscular in the thigh on 02Mar2020 at single dose for prophylactic vaccination, diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (INFANRIX HEXA, lot number: A21CD582A), intramuscular in the thigh on 02Mar2020 at unspecified dose and frequency for prophylactic vaccination. Medical history included pneumonia on 12Jan2020 to an unspecified date. The patient was a premarture baby (32+1 pregnancy week), inpatient due to RSV pneumonia from 12Jan2020 to 31Jan2020, ventilated from 12Jan2020 to 25Jan2020, intubated and ventilated from 19Jan2020 to 20Jan2020. The patient''s concomitant medications were not reported. Patient''s death on 11Mar2020 was reported. The patient died on 11Mar2020. It was not reported if an autopsy was performed. Causality assessment for Prevenar 13 and Infanrix Hexa/Death: Agency,,D. Unclassifiable Sender''s comment: Previous medical history: premature baby 32+1 pregnancy week due to premature labor and premature amniorrhexis, Complication-free course. From 12Jan2020 to 31Jan2020 inpatient due to RSV pneumonia. From 12Jan2020 to 25Jan2020 ventilated, thereby from 19Jan2020 to 20Jan2020 intubated and ventilated. Scheduled admission for the first vaccination from 02Mar2020 to 04Mar2020 (Prevenar 13, lot number CD1581 and Infanrix Hexa Lot number A21CD582A). No follow-up attempts needed, follow-up automatically provided by Regulatory Authority.; Reported Cause(s) of Death: Unknown cause of death


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: 866582 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2020-02-19
Onset:2020-03-04
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2020-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH AH5529AJ6040 / 1 LL / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Death, Decreased appetite, Mental disorder, Pneumonia, Pulmonary function test decreased, Respiratory failure
SMQs:, Anaphylactic reaction (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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-04
   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: CNPFIZER INC2020132604

Write-up: respiratory failure due to severe pneumonia; respiratory failure due to severe pneumonia; respiratory failure due to severe pneumonia; Decreased appetite; slight cough; poor mental state; This is a spontaneous report from a contactable physician via a sales representative. A 4-months-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, lot: AH5529AJ6040), on her first injection on 19Feb2020 at age of 3 months, on left thigh via muscle injection, at single dose for immunization. The medical history and concomitant medications were not reported. After injection, patient had decreased appetite gradually, poor mental state and sometimes slight cough in 2020. On 04Mar2020, patient went to hospital and was clinically diagnosed with severe pneumonia, respiratory failure and half of pulmonary function loss, patient died on that day. Community physician considered that the symptoms were not caused by PREVENAR 13, patient died of respiratory failure due to severe pneumonia. Physician considered that all events were possibly not related to PREVENAR 13. No autopsy was performed and the physician was not sure that whether the patient had congenital heart disease or not. The outcome of respiratory failure due to severe pneumonia was fatal. The outcome of other events was unknown. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results are needed for full medical 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: respiratory failure due to severe pneumonia; respiratory failure due to severe pneumonia; respiratory failure due to severe pneumonia


VAERS ID: 866666 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-02-17
Onset:2016-02-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2020AP

Write-up: vaccine taken and dose: HepB2 + tOPV1; This case was reported in a literature article and described the occurrence of unknown cause of death in a 5-month-old patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included POLIOVIRUS VACCINE LIVE ORAL (TRIVALENT ORAL POLIOMYELITIS VACCINE) for prophylaxis. On 17th February 2016, the patient received the 2nd dose of Hepatitis B vaccine and the 1st dose of TRIVALENT ORAL POLIOMYELITIS VACCINE. On 17th February 2016, less than a day after receiving Hepatitis B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. An autopsy was not performed. It was unknown if the reporter considered the unknown cause of death to be related to Hepatitis B vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of death in 5-month-old patient of unspecified gender, who was vaccinated with unspecified hepatitis vaccine (HBV) and unspecified trivalent oral polio vaccine (tOPV) vaccine (manufacturer unknown for both) for prophylaxis. This case corresponds to table 3 reported in this literature article. The patient was the part of study that object was to determine incidence rates of adverse events Following immunization (AEFIs) with hepatitis B vaccine (HepB). The study was conducted in order to systematically analyze the occurrence of AEFI after Hepatitis B vaccination, objectively evaluate the safety of Hepatitis B, maintain the public''s trust in vaccination, and maintain the high vaccination rate of HepB, this Paper analyses the monitoring data of Hepatitis B AEFI in 2016-2018. No information on patient''s family history or medical history or concurrent condition or concomitant medication was provided. On 17 February 2016, the patient was vaccinated with 2nd dose of unspecified HBV and 1st dose of unspecified tOPV vaccine (administration route and site unspecified; batch number not provided for both). On 17 February 2016, less than a day after vaccination, the patient was died. The patient''s cause of death was unknown. The patient''s autopsy was not performed. This case has been considered as serious due to death. The reporter did not comment on relationship between the event death and unspecified HBV and unspecified tOPV The authors stated, "HepB AEFI reported by the monitoring system mainly occurred one day after HepB vaccination, and death cases mainly occurred one day after HepB vaccination, similar to that reported in other provinces. HepB AEFI outcomes were mostly approved; the main cause of AEFI death was concomitant disease (concomitant disease refers to the fact that the recipient was in the incubation period of a certain disease, or there is a basic disease that has not been found yet, after vaccination, the incidence of coincidence has nothing to do with the vaccine itself, mainly pneumonia and accidental death caused by early coupling infection. HepB was vaccinated early in the baby''s life (0, 1, 6 months), when infections and other underlying congenital or neurological diseases are more common. In 2016-2018, the infant mortality rate in Province was between 6.70 ? and 8.23 ?. Based on 600,000 children born each year, the number of infant deaths per year is 4,020-4,938. According to HepB AEFI surveillance data from Province and related studies in other parts of area, concomitant diseases are the leading cause of death following HepB vaccination (73.33%), and deaths directly caused by vaccination are extremely rare". The Author concluded "The progress from vaccination to death of the cases of concomitant disease was rapid, lacking clinical diagnosis and treatment data, so it was suggested to carry out autopsy for the death cases as far as possible to clarify the cause of death. It was suggested to do best in the screening of early congenital diseases of infants so as to early detect and avoid vaccination contraindications. Secondly, the newborns with HBsAg positive mothers must be vaccinated with HepB within 24 hours to prevent mother-to-child transmission of hepatitis B. However, for the newborns born to healthy pregnant women, it is necessary to correctly evaluate the health of the newborns when it is clear that there is no risk of infection. If there are very low birth weight, serious birth defects, severe asphyxia, respiratory distress syndrome etc., the first dose of HepB should be inoculated after the vital signs are stable. At the same time, it was necessary to improve the diagnostic rate and level of AEFI in the investigation and diagnosis expert group of adverse events following immunization at all levels, and carefully study and judge the cases of serious adverse events'''' This article is not available for regulatory submission due to copyright restriction. This is 1 of the 4 valid case reported in this literature article.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 866667 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-07-22
Onset:2016-07-01
Submitted: 0000-00-00
Entered: 2020-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2020GS

Write-up: Abnormal reaction (shock); This case was reported in a literature article and described the occurrence of shock in a 5-week-old patient who received Hepatitis B vaccine for prophylaxis. On 22nd July 2016, the patient received the 2nd dose of Hepatitis B vaccine. In July 2016, less than a week after receiving Hepatitis B vaccine, the patient experienced shock (serious criteria death and GSK medically significant). On an unknown date, the outcome of the shock was fatal. The reported cause of death was shock. An autopsy was not performed. It was unknown if the reporter considered the shock to be related to Hepatitis B vaccine. Additional details were provided follows: This case was reported in a literature article and described the occurrence of Abnormal reaction (shock) in 5-weeks-old patient of unspecified gender, who was vaccinated with unspecified hepatitis vaccine (HBV) (manufacturer unknown) for prophylaxis. The patient was the part of study that object was to determine incidence rates of adverse events Following immunization (AEFIs) with hepatitis B vaccine (HepB). The study was conducted in order to systematically analyze the occurrence of AEFI after Hepatitis B vaccination, objectively evaluate the safety of Hepatitis B, maintain the public''s trust in vaccination, and maintain the high vaccination rate of HepB, this Paper analyses the monitoring data of Hepatitis B AEFI in 2016-2018. No information on patient''s family history or medical history or concurrent condition or concomitant medication was provided. On 22 July 2016, the patient was vaccinated with 2nd dose of unspecified HBV (administration route and site unspecified; dosage unknown; batch number not provided). On an unspecified date in July 2016, 2 to 3 days after vaccination, the patient experienced abnormal reaction (shock) and the patient was died. [In this study, 31 patients experienced abnormal reaction as allergic rash, 1 patient experienced angioedema, 1 with allergic purpura, 1 with thrombocytopenic purpura, 5 with other allergic reactions and 1 experienced branchial nerve injury]. The patient''s cause of death was abnormal reactions (shock). The patient''s autopsy was not performed. This case has been considered as serious due to death. The reporter did not comment on relationship between the event abnormal reactions (shock) and unspecified HBV. The authors stated, "HepB AEFI reported by the monitoring system mainly occurred one day after HepB vaccination, and death cases mainly occurred one day after HepB vaccination, similar to that reported in other provinces. HepB AEFI outcomes were mostly approved; the main cause of AEFI death was concomitant disease (concomitant disease refers to the fact that the recipient was in the incubation period of a certain disease, or there is a basic disease that has not been found yet, after vaccination, the incidence of coincidence has nothing to do with the vaccine itself, mainly pneumonia and accidental death caused by early coupling infection. HepB was vaccinated early in the baby''s life (0, 1, 6 months), when infections and other underlying congenital or neurological diseases are more common. In 2016-2018, the infant mortality rate in this Province was between 6.70 ? and 8.23 ?. Based on 600,000 children born each year, the number of infant deaths per year is 4,020-4,938. According to HepB AEFI surveillance data from this Province and related studies in other parts of the country, concomitant diseases are the leading cause of death following HepB vaccination (73.33%), and deaths directly caused by vaccination are extremely rare". The Author concluded "The progress from vaccination to death of the cases of concomitant disease was rapid, lacking clinical diagnosis and treatment data, so it was suggested to carry out autopsy for the death cases as far as possible to clarify the cause of death. It was suggested to do best in the screening of early congenital diseases of infants so as to early detect and avoid vaccination contraindications. Secondly, the newborns with HBsAg positive mothers must be vaccinated with HepB within 24 hours to prevent mother-to-child transmission of hepatitis B. However, for the newborns born to healthy pregnant women, it is necessary to correctly evaluate the health of the newborns when it is clear that there is no risk of infection. If there are very low birth weight, serious birth defects, severe asphyxia, respiratory distress syndrome etc., the first dose of HepB should be inoculated after the vital signs are stable. At the same time, it was necessary to improve the diagnostic rate and level of AEFI in the investigation and diagnosis expert group of adverse events following immunization at all levels, and carefully study and judge the cases of serious adverse events'''' This article is not available for regulatory submission due to copyright restriction. This is 1 of the 4 valid case reported in this literature article.; Reported Cause(s) of Death: shock


VAERS ID: 866668 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-09-08
Onset:2017-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2020GS

Write-up: death; This case was reported in a literature article and described the occurrence of unknown cause of death in a neonate patient who received Hepatitis B vaccine for prophylaxis. On 8th September 2017, the patient received the 1st dose of Hepatitis B vaccine. On 8th September 2017, less than a day after receiving Hepatitis B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. An autopsy was not performed. It was unknown if the reporter considered the unknown cause of death to be related to Hepatitis B vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of death in patient of unspecified gender, who was vaccinated with unspecified hepatitis vaccine (HBV) (manufacturer unknown) for prophylaxis. The patient was the part of study that object was to determine incidence rates of adverse events Following immunization (AEFIs) with hepatitis B vaccine (HepB). The study was conducted in order to systematically analyze the occurrence of AEFI after Hepatitis B vaccination, objectively evaluate the safety of Hepatitis B, maintain the public''s trust in vaccination, and maintain the high vaccination rate of HepB, this Paper analyses the monitoring data of Hepatitis B AEFI in 2016-2018. The patient was born on 8 September 2017. No information on patient''s family history or medical history or concurrent condition or concomitant medication was provided. On 8 September 2017, the patient was vaccinated with 1st dose of unspecified HBV (administration route and site unspecified; batch number not provided). On 8 September 2017, less than a day after vaccination, the patient was died. The patient''s cause of death was unknown. The patient''s autopsy was not performed. This case has been considered as serious due to death. The reporter did not comment on relationship between the event death and unspecified HBV. The authors stated, "HepB AEFI reported by the monitoring system mainly occurred one day after HepB vaccination, and death cases mainly occurred one day after HepB vaccination, similar to that reported in other provinces. HepB AEFI outcomes were mostly approved; the main cause of AEFI death was concomitant disease (concomitant disease refers to the fact that the recipient was in the incubation period of a certain disease, or there is a basic disease that has not been found yet, after vaccination, the incidence of coincidence has nothing to do with the vaccine itself, mainly pneumonia and accidental death caused by early coupling infection. HepB was vaccinated early in the baby''s life (0, 1, 6 months), when infections and other underlying congenital or neurological diseases are more common. In 2016-2018, the infant mortality rate in specific region was between 6.70 ? and 8.23 ?. Based on 600,000 children born each year, the number of infant deaths per year is 4,020-4,938. According to HepB AEFI surveillance data and related studies in other parts of country, concomitant diseases are the leading cause of death following HepB vaccination (73.33%), and deaths directly caused by vaccination are extremely rare". The Author concluded "The progress from vaccination to death of the cases of concomitant disease was rapid, lacking clinical diagnosis and treatment data, so it was suggested to carry out autopsy for the death cases as far as possible to clarify the cause of death. It was suggested to do best in the screening of early congenital diseases of infants so as to early detect and avoid vaccination contraindications. Secondly, the newborns with HBsAg positive mothers must be vaccinated with HepB within 24 hours to prevent mother-to-child transmission of hepatitis B. However, for the newborns born to healthy pregnant women, it is necessary to correctly evaluate the health of the newborns when it is clear that there is no risk of infection. If there are very low birth weight, serious birth defects, severe asphyxia, respiratory distress syndrome etc., the first dose of HepB should be inoculated after the vital signs are stable. At the same time, it was necessary to improve the diagnostic rate and level of AEFI in the investigation and diagnosis expert group of adverse events following immunization at all levels, and carefully study and judge the cases of serious adverse events'''' This article is not available for regulatory submission due to copyright restriction. This is 1 of the 4 valid case reported in this literature article; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 866669 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Unknown  
Location: Foreign  
Vaccinated:2018-12-07
Onset:2018-12-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2020GS

Write-up: Death; This case was reported in a literature article and described the occurrence of unknown cause of death in a 6-week-old patient who received Hepatitis B vaccine for prophylaxis. On 7th December 2018, the patient received the 2nd dose of Hepatitis B vaccine. On 7th December 2018, less than a day after receiving Hepatitis B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. An autopsy was not performed. It was unknown if the reporter considered the unknown cause of death to be related to Hepatitis B vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of death in 6-weeks-old patient of unspecified gender, who was vaccinated with unspecified hepatitis vaccine (HBV) (manufacturer unknown) for prophylaxis. This case corresponds to table 3 reported in this literature article. The patient was the part of study that object was to determine incidence rates of adverse events Following immunization (AEFIs) with hepatitis B vaccine (HepB). The study was conducted in order to systematically analyze the occurrence of AEFI after Hepatitis B vaccination, objectively evaluate the safety of Hepatitis B, maintain the public''s trust in vaccination, and maintain the high vaccination rate of HepB, this Paper analyses the monitoring data of Hepatitis B AEFI in 2016-2018. No information on patient''s family history or medical history or concurrent condition or concomitant medication was provided. On 7 December 2018, the patient was vaccinated with 2nd dose of unspecified HBV vaccine (administration route and site unspecified; batch number not provided). On 7 December 2018, less than a day after vaccination, the patient was died. The patient''s cause of death was unknown. The patient''s autopsy was not performed. This case has been considered as serious due to death. The reporter did not comment on relationship between the event death and unspecified HBV. The authors stated, "HepB AEFI reported by the monitoring system mainly occurred one day after HepB vaccination, and death cases mainly occurred one day after HepB vaccination, similar to that reported in other provinces. HepB AEFI outcomes were mostly approved; the main cause of AEFI death was concomitant disease (concomitant disease refers to the fact that the recipient was in the incubation period of a certain disease, or there is a basic disease that has not been found yet, after vaccination, the incidence of coincidence has nothing to do with the vaccine itself, mainly pneumonia and accidental death caused by early coupling infection. HepB was vaccinated early in the baby''s life (0, 1, 6 months), when infections and other underlying congenital or neurological diseases are more common. In 2016-2018, the infant mortality rate in Province was between 6.70 ? and 8.23 ?. Based on 600,000 children born each year, the number of infant deaths per year is 4,020-4,938. According to HepB AEFI surveillance data from Province and related studies in other parts of area, concomitant diseases are the leading cause of death following HepB vaccination (73.33%), and deaths directly caused by vaccination are extremely rare". The Author concluded "The progress from vaccination to death of the cases of concomitant disease was rapid, lacking clinical diagnosis and treatment data, so it was suggested to carry out autopsy for the death cases as far as possible to clarify the cause of death. It was suggested to do best in the screening of early congenital diseases of infants so as to early detect and avoid vaccination contraindications. Secondly, the newborns with HBsAg positive mothers must be vaccinated with HepB within 24 hours to prevent mother-to-child transmission of hepatitis B. However, for the newborns born to healthy pregnant women, it is necessary to correctly evaluate the health of the newborns when it is clear that there is no risk of infection. If there are very low birth weight, serious birth defects, severe asphyxia, respiratory distress syndrome etc., the first dose of HepB should be inoculated after the vital signs are stable. At the same time, it was necessary to improve the diagnostic rate and level of AEFI in the investigation and diagnosis expert group of adverse events following immunization at all levels, and carefully study and judge the cases of serious adverse events'''' This article is not available for regulatory submission due to copyright restriction. This is 1 of the 4 valid case reported in this literature article.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 866869 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Congestive cardiomyopathy, Death, Disseminated varicella zoster vaccine virus infection, Gastrointestinal disorder, Leukopenia, Lung disorder, Multiple organ dysfunction syndrome, Thrombocytopenia
SMQs:, Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Cardiomyopathy (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Opportunistic infections (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: hydroxychloroquine sulfate; methotrexate; prednisone
Current Illness: Antiviral prophylaxis; Rheumatoid arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA0095075132003CAN011081

Write-up: congestive cardiomyopathy; disseminated varicella zoster vaccine virus infection; gastrointestinal disorder; leukopenia; lung disorder; multiple organ dysfunction syndrome; thrombocytopenia; Information has been received from Health Agency (Agency number E2B_02854079) on 30-MAR-2020, referring to a 70-year-old male patient. The patient''s concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were reported. On an unknown date, the patient was vaccinated with zoster vaccine (manufacturer unknown), route of administration unknown, as antiviral prophylaxis (dosage form, strength, dose, frequency, anatomical location, lot# and expiration date not reported). On an unknown date, the patient started other suspect therapies hydroxychloroquine sulfate route of administration unknown, 200 milligram, 1 every 1 day, for Rheumatoid arthritis (dosage form, strength lot# and expiration date not reported); methotrexate dosage form not specified, route of administration unknown, 2.5 milligram, 1 every 1 days for rheumatoid arthritis (strength, lot# and expiration date not reported); and prednisone dosage form not specified, route of administration unknown, 10 milligram, 1 every 1 days for rheumatoid arthritis (strength, lot# and expiration date not reported). On an unknown date, the patient experienced congestive cardiomyopathy, disseminated varicella zoster vaccine virus infection, gastrointestinal disorder, leukopenia, lung disorder, multiple organ dysfunction syndrome, thrombocytopenia. On an unknown date, the patient was hospitalized due to the events, and on an unspecified date, the patient passed away from the events. It was unknown if an autopsy was performed. Action taken with the suspect therapies and causality assessment was not provided.


VAERS ID: 867004 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Death
SMQs:, Noninfectious encephalitis (narrow), Demyelination (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2020SA080552

Write-up: acute disseminated encephalomyelitis (ADEM); Initial information received from a valid serious literature article on 24-Mar-2020. Literature citation:. This case was linked to cases 2020SA080564 and 2020SA080565 (same article). This case involves a 40 years old male patient who experienced acute disseminated encephalomyelitis (acute disseminated encephalomyelitis), while he received vaccines TYPHOID VACCINE and HEPATITIS A VACCINE. The patient''s medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect HEPATITIS A VACCINE and TYPHOID VACCINE (produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, for both vaccines) for prophylactic vaccination. On an unknown date, the patient developed a serious acute disseminated encephalomyelitis (ADEM) (acute disseminated encephalomyelitis) unknown latency following the administration of HEPATITIS A VACCINE and TYPHOID VACCINE. This event was assessed as medically significant and was leading to death. Patient died 2 weeks after receiving these vaccines (Date of death was not reported). Case report: A 40 years old male died 2 weeks after receiving a dose of hepatitis A vaccine and a dose of the typhoid vaccine. These vaccines are not included in the NIP. The cause of death was acute dis-seminated encephalomyelitis (ADEM). No laboratory data was available. Final diagnosis was (fatal) acute disseminated encephalomyelitis (ADEM). It was not reported if the patient received a corrective treatment. The patient outcome was Fatal for acute disseminated encephalomyelitis. It was unknown if an autopsy was done. The cause of death was reported as Acute disseminated encephalomyelitis. The causality was investigated by the health authority (Health Authority) and based on the information received from reporters, no clear causal relationship with vaccination was found. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a 40 years old male patient who died from acute disseminated encephalomyelitis (ADEM) 2 weeks post vaccination with Hepatitis A vaccine and Typhoid vaccine (produced by unknown manufacturer). The time to onset was unknown. There were no medical history, past medication or concomitant therapy reported. No examination reports of brain and spinal cord were provided. It was also not specified if patient followed proper routine vaccinations or not. The causality was investigated by the Health Authority and based on the information received from reporters, no clear causal relationship with vaccination was found. However, patient''s comorbidities, virological examination reports along with autopsy results should be provided to access further. Based on the limited information, the individual role of vaccine cannot be assessed.; Reported Cause(s) of Death: acute disseminated encephalomyelitis (ADEM)


VAERS ID: 867030 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-03-16
Onset:2020-03-23
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2020-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Dysphagia, Encephalitis viral, General physical health deterioration, Hallucination, Oropharyngeal pain, Pyrexia, Rabies
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-25
   Days after onset: 2
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: IMMUNOGLOBULIN ANTI-RABIES
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYSA2020SA078344

Write-up: rabies encephalitis; rabies encephalitis; fever; condition deteriorated; difficulty swallowing; hallucinations; sore throat; Initial information received on 30-Mar-2020 regarding an unsolicited valid serious case received from a consumer/non-hcp This case involves a five-years old female patient who died due to rabies encephalitis (encephalitis viral) with sore throat (oropharyngeal pain), fever (pyrexia), difficulty swallowing (dysphagia), hallucinations (hallucination) and condition deteriorated (condition aggravated), while she received vaccines RABIES VACCINE and TETANUS TOXOID and while treated with IMMUNOGLOBULIN ANTI-RABIES. The patient''s medical history included Animal bite on 08-MAR-2020. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received first and second dose of RABIES VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for post-exposure immunization. On 16-Mar-2020, the patient received a third dose of suspect RABIES VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for post-exposure immunization. On an unknown date, the patient received a dose of IMMUNOGLOBULIN ANTI-RABIES (rabies immunoglobulin Jab) not produced by Sanofi Pasteur via unknown route unknown and unknown administration site (with an unknown batch number) for Animal bite. On 23-Mar-2020, the patient developed a serious sore throat (oropharyngeal pain), difficulty swallowing (dysphagia) and hallucinations (hallucination) unknown latency following first two doses of Rabies vaccine and 7 days following third dose of rabies vaccine and unknown latency following intake of IMMUNOGLOBULIN ANTI-RABIES and TETANUS TOXOID. On an unknown date, the patient experienced serious fever (pyrexia) and condition deteriorated (condition aggravated) unknown latency following vaccination with rabies vaccine, IMMUNOGLOBULIN ANTI-RABIES and TETANUS TOXOID. On an unknown date, the patient developed rabies encephalitis (encephalitis viral) unknown latency following vaccination with rabies vaccine, IMMUNOGLOBULIN ANTI-RABIES and TETANUS TOXOID. The patient was hospitalized for these events. These all events were medically significant and led to death of the patient. Case details: it was reported that the patient was bitten in the face by a stray dog on March 8, but the wounds were not immediately washed with running water and soap. She was brought to Hospital for treatment the same day. She received an anti-tetanus jab, a rabies immunoglobulin jab and two doses of anti-rabies vaccine. On March 13, she was discharged in healthy condition, said in a statement on Monday (March 30). The patient was given a third anti-rabies vaccine jab on March 16. On March 24, the patient was brought to a community clinic in for fever and to Hospital the next day after suffering a sore throat, difficulty swallowing and hallucinations. Her condition deteriorated and she died the following day. The cause of death was rabies encephalitis. No laboratory data reported. Final diagnosis was (fatal) rabies encephalitis. It was not reported if the patient received any corrective treatment. The event outcome was fatal and the patient died on 25-Mar-2020. It is unknown if an autopsy was done. The cause of death was reported as Encephalitis viral, Oropharyngeal pain, Pyrexia, Dysphagia, Hallucination and Condition aggravated. There will be no information available on the batch number for this case.; Sender''s Comments: This five-year-old patient bitten on the face by a rabid dog, developed rabies and died despite post-exposure prophylaxis including RABIES VACCINE (three doses), TETANUS TOXOID and IMMUNOGLOBULIN ANTI-RABIES, all from unknown manufacturer. Reportedly, immediate wound cleaning was not provided. Rabies post-exposure prophylaxis (PEP) was started on the day of exposure. Overall, the patient received 3 doses of rabies vaccine, last dose administered 8 days after exposure (exact schedule not reported). The details of Rabies immunoglobulin and vaccine (type, manufacturer, dose, route and site of administration) were not reported. Sixteen days after exposure, the patient developed clinical rabies (sore throat, fever, difficulty swallowing and hallucinations) and died the following day. The cause of death was reported as rabies encephalitis, although it is unknown whether the autopsy was done or not. Lack of immediate wound cleaning and bite on the face which is highly innervated area could have significantly contributed to PEP failure. Based on limited information provided on rabies vaccine and immunoglobulin administration, a detailed assessment on the role of vaccine is not possible.; Reported Cause(s) of Death: rabies encephalitis


VAERS ID: 867124 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRID BIOMEDICAL CORPORATI

Write-up: reactions to the flu vaccine; reactions to the flu vaccine and was hospitalized and died; This case was reported by a consumer and described the occurrence of unknown cause of death in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and adverse event (serious criteria hospitalization). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the adverse event was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and adverse event to be related to Flu vaccine. Additional details were reported as follows: The age at vaccination was not reported. The reporter informed about the death of a company colleague. The patient received flu vaccine through the company flu vaccination campaign and had reactions to the flu vaccine. The patient was then hospitalized and died. The reporter informed that she did not have any other information about this case and she was not close to the family of patient. Follow up not possible. No other information was provided.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 867360 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Basilar migraine, Blood glucose increased, Cardiac arrest, Confusional state, Crying, Death, Dizziness postural, Drowning, Gait inability, Headache, Loss of consciousness, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: influenza virus vaccine (unspecified); YASMIN 28
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA0095075132004CAN001023

Write-up: Asthenia; Basilar migraine; Blood glucose increased; Cardiac arrest; Confusional state; Crying; Dizziness postural; Drowning; Gait inability; Headache; Loss of consciousness; Syncope; vomiting; This spontaneous report was received from a physician via health Agency (Agency#: E2B_02830843) referring to a 14 years old female patient. No information regarding current condition or medical history was provided. The patient''s concomitant therapy included influenza virus vaccine (unspecified). On an unknown date, the patient was vaccinated with a human papillomavirus (HPV) vaccine (manufacturer unknown) (frequency: total, therapy duration: 1 day, name, lot#, expiration date and dose detail were not provided) via subcutaneous route for immunization. On an unknown date, the patient was vaccinated with another HPV vaccine (manufacturer unknown) (frequency: total, therapy duration: 1 day, name, lot#, expiration date, route and dose detail were not provided) for immunization. On an unknown date, the patient started therapy with drospirenone (+) ethinyl estradiol (YASMIN 28) (dosage form: tablets, strength, dose, frequency, route, lot# and expiration date were not reported) for an unknown indication. On unknown dates, the patient experienced asthenia, basilar migraine, blood glucose increased, cardiac arrest (reaction duration was 1 day), confusional state, crying, dizziness postural, drowning gait inability, headache, loss of consciousness, syncope and vomiting. Therapy with drospirenone (+) ethinyl estradiol (YASMIN 28) was not reported. The patient was hospitalized due to all above events. The outcome of all above events was fatal. The cause of death was not provided. It was unknown if autopsy was performed. The causality assessment between all above events and suspect therapies was not reported. All above events were determined to be medically significant by the agency.


VAERS ID: 867501 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Brain death, Brain injury, Brain oedema, Cardio-respiratory arrest, Death, Diabetes insipidus, Electroencephalogram abnormal, Endotracheal intubation, Enterovirus infection, Enterovirus test positive, Hyperglycaemia, Hypertension, Hyperthermia, Hypoxic-ischaemic encephalopathy, Intensive care, Magnetic resonance imaging brain abnormal, Pneumonia, Pulmonary oedema, Pyrexia, Staring, Status epilepticus, Tardive dyskinesia, Tonic clonic movements, Unresponsive to stimuli, Withdrawal of life support
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Dyskinesia (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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: Familial risk factor; Gene mutation
Preexisting Conditions: Medical History/Concurrent Conditions: Fever (lasting 1?2 weeks); Full term baby; Omphalitis; Rhinorrhoea (lasting 1?2 weeks)
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075132004AUS001523

Write-up: status epilepticus following vaccination; This literature marketed report has been received from the authors of the published article, concerning a 12-month-old boy, born at full-term via spontaneous vaginal delivery to non-consanguineous parents (first pregnancy via in-vitro fertilisation). His mother had epilepsy from infancy, with her first febrile seizure (FS) before 12 months old. She progressed to have both febrile and afebrile bilateral tonic clonic seizures, but no focal seizures or status epilepticus. Her seizures were managed with sodium valproate only. Seizure frequency decreased from once every two months from infancy to puberty, to being seizure free for 4 years before ceasing medication for 5 years before the patient''s birth. There was no significant neurodevelopmental impact from the seizures, and she completed high school studies with no assistance. There was a history of epilepsy in her older sister and her father''s family. No family members had prolonged seizures or developmental concerns. The patient was a healthy infant with normal growth and development and no significant medical history aside from omphalitis as a neonate. He received his first three sets of infant vaccinations diphtheria toxoid (+) hepatitis B virus vaccine (unspecified) (+) Hib conj vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine (unspecified) (+) tetanus toxoid, pneumococcal 13v conj vaccine and rotavirus vaccines at 6 weeks and 4 months and diphtheria toxoid (+) hepatitis B virus vaccine (unspecified) (+) Hib conj vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) poliovirus vaccine (unspecified) (+) tetanus toxoid and pneumococcal 13v conj vaccine at 6 months with no adverse events following immunisation. At 12 months old, he had a mild febrile illness with rhinorrhea lasting 1?2 weeks and had been afebrile for 3?4 days at the time of hib conj vaccine (tet toxoid), meningococcal c conj vaccine (tet toxoid) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccinations. Approximately 27 h later, his first seizure occurred. The child was staring, unresponsive with lip smacking, followed by bilateral tonic clonic movements. Fever to 38.5 degree Celsius was recorded on arrival to emergency. Four doses of midazolam were given before status epilepticus terminated at approximately 40 min. He went into cardiopulmonary arrest during intubation and had 40 min of down time before return of spontaneous circulation on an adrenalin infusion. A loading dose of levetiracetam (30 mg/kg) was given and he was transferred to paediatric intensive care unit on morphine and adrenaline infusion. Antibiotics were commenced, cerebrospinal fluid (CSF) collection was deferred. Computerized tomography (CT) brain showed severe global hypoxic ischemic brain injury with cerebral oedema. The admission was complicated by pulmonary oedema, secondary pneumonia, diabetes insipidus, hyperglycaemia, hyperthermia and hypertension. Electroencephalogram (EEG) showed electrocerebral silence, and magnetic resonance imaging (MRI) re-demonstrated extensive changes with cerebellar tonsillar herniation and absence of flow in the intracranial arteries on Magnetic Resonance Angiography (MRA) consistent with brain death; medical support was withdrawn, and he died. The patient died from hypoxic ischemic encephalopathy following his 12-month vaccinations, in the context of status epilepticus and enterovirus 71 infection. Autopsy found severe cerebral oedema with diffuse hypoxic ischemic encephalopathy changes and cerebellar tonsillar herniation. There was also extensive bronchopneumonia. Enterovirus 71 was found on tracheal and rectal swab. There were no signs of meningitis or encephalitis on neuropathological exam of brain and spinal cord. Genomic testing was not performed at the time of autopsy. Whole exome sequencing was arranged on a stored liver-derived DNA sample, focusing on a panel of SUDEP (sudden unexpected death in epilepsy), long QT syndrome and hypoventilation- associated genes. The detected heterozygous missense variant in SCN1A (NM_001165963.1: c.2866A$gG;p.(Met956Val)) was novel and classified as likely pathogenic by Regulatory Authority guidelines (Class 4: PM2, PM5, PP2, PP3). While this was a novel amino acid change, other pathogenic missense changes affecting the same residue, including p.Met956Thr, have been reported where in vitro studies demonstrate reduced cell surface SCN1A expression, highlighting the functional importance of this particular highly conserved methionine. The absence of variants in this position in population databases including Genome Aggregation Database (gnomAD) and in silico predictions support this missense variant as being likely pathogenic. This variant was also subsequently found in the mother. A copy of the published article is attached as further documentation of the patient''s experience.; Reported Cause(s) of Death: hypoxic ischemic encephalopathy; Autopsy-determined Cause(s) of Death: cerebellar tonsillar herniation; extensive bronchopneumonia; Enterovirus 71 was found on tracheal and rectal swab


VAERS ID: 867659 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes ((under control)); Pulmonary embolism (Diagnosed)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZERINC2020142542

Write-up: 2 months ago was taken to hospital due to myocardial infarction and died; This is a spontaneous report from a contactable physician via a sales representative. A 48/50 years old female patient started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13), via an unspecified route of administration at single dose on an unspecified date (4 months ago) for immunisation. Medical history included diabetes (under control), pulmonary embolism (diagnosed). Concomitant medications were not reported. On an unspecified date, the patient experienced that 2 months ago was taken to hospital due to myocardial infarction and died. The patient died on an unspecified date. It was not reported if an autopsy was performed. The relatives of the patients ask if it could be caused by the vaccine. The patient''s relative asking if death might be related with the vaccine. The information on the Lot / Batch number has been requested.; Sender''s Comments: There is no reasonable possibility that the event fatal myocardial infection was related to pneumococcal 13-valent conjugate vaccine use. This is more likely associated with the medical history of pulmonary embolism and intercurrent conditions.; Reported Cause(s) of Death: 2 month ago was taken to hospital due to MI and died


VAERS ID: 867723 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-01-17
Onset:2020-01-28
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2020-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Death, Incorrect route of product administration, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Medication errors (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2020-01-28
   Days after onset: 0
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: Medical History/Concurrent Conditions: Atrial fibrillation; Coronary heart disease (In May 2012); Hyperlipoproteinemia; Transient ischemic attack (In March 2012)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE202005

Write-up: cardiopulmonary shock; Ventricular fibrillation; Inappropriate route of vaccine adminstered; This case was reported by a physician via regulatory authority and described the occurrence of cardiogenic shock in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient''s past medical history included atrial fibrillation, transient ischemic attack (In March 2012), hyperlipoproteinemia and coronary heart disease (In May 2012). Previously administered products included Shingrix (On 11th September 2019). On 17th January 2020, the patient received Shingrix (subcutaneous). On 28th January 2020, 11 days after receiving Shingrix, the patient experienced cardiogenic shock (serious criteria death, hospitalization, GSK medically significant and life threatening) and ventricular fibrillation (serious criteria death, hospitalization, GSK medically significant and life threatening). On an unknown date, the patient experienced intramuscular formulation administered by other route. On 28th January 2020, the outcome of the cardiogenic shock and ventricular fibrillation were fatal. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. The patient died on 28th January 2020. The reported cause of death was cardiogenic shock. An autopsy was not performed. It was unknown if the reporter considered the cardiogenic shock and ventricular fibrillation to be related to Shingrix. Additional details: The age at vaccination was not provided but the patient could be 83 years old or less than 83 years old. Shingrix should be administered via intramuscular route. However the patient received shingrix via subcutaneous route, which led to intramuscular formulation administered by other route. Initial information was reported by a Physician via regulatory authority on 1st April 2020: Cardiogenic shock , ventricular fibrillation and intramuscular formulation administered by other route.; Reported Cause(s) of Death: Cardiogenic shock


VAERS ID: 867878 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Brain death, Brain herniation, Brain oedema, Cardio-respiratory arrest, Computerised tomogram head abnormal, Diabetes insipidus, Electroencephalogram abnormal, Enterovirus infection, Enterovirus test positive, Febrile convulsion, Hyperglycaemia, Hypertension, Hyperthermia, Hypoxic-ischaemic encephalopathy, Magnetic resonance imaging brain abnormal, Pneumonia, Pulmonary oedema, Pyrexia, Rhinorrhoea, Staring, Status epilepticus, Tardive dyskinesia, Tonic clonic movements, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Dyskinesia (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy (patient mother had from infancy); Febrile seizure (patient mother had before 12 months old); Omphalitis; Tonic-clonic seizures (patient mother managed it with sodium valproate only)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: 38.5, Test Result Unit: degree C; Test Name: Electroencephalogram; Result Unstructured Data: Test Result: showed electrocerebral silence; Test Name: Magnetic resonance imaging; Result Unstructured Data: Test Result: see text; Test Name: Viral swab; Result Unstructured Data: Test Result: Enterovirus 71 was found
CDC Split Type: AUGLAXOSMITHKLINEAU2020GS

Write-up: Seizure; cardiopulmonary arrest during intubation; pulmonary oedema; Staring; unresponsive with lip smacking; unresponsive with lip smacking; bilateral tonic clonic movements; Status epilepticus; secondary pneumonia/extensive bronchopneumonia; Enterovirus 71; hyperglycaemia; hyperthermia; hypertension; fever/mild febrile illness; diabetes insipidus; Brain death; severe cerebral oedema; diffuse hypoxic ischemic encephalopathy; extensive changes with cerebellar tonsillar herniation; rhinorrhea; This case was reported in a literature article and described the occurrence of brain death in a 12-month-old male patient who received DTPa-HBV-IPV+Hib (DTPa-HBV-IPV-HIB) for prophylaxis. Co-suspect products included DTPa-HBV-IPV+Hib (DTPa-HBV-IPV-HIB) for prophylaxis, DTPa-HBV-IPV+Hib (DTPa-HBV-IPV-HIB) for prophylaxis, Rotavirus vaccine for prophylaxis, Rotavirus vaccine for prophylaxis, Hib-MenC-TT (HIB and Meningitis C vaccine) for prophylaxis, MMR (MMR vaccine) for prophylaxis, 13-VALENT PNEUMOCOCCAL CONJUGATE for prophylaxis, 13-VALENT PNEUMOCOCCAL CONJUGATE for prophylaxis and 13-VALENT PNEUMOCOCCAL CONJUGATE for prophylaxis. The patient''s past medical history included omphalitis. The patient had a Family History of epilepsy (patient mother had from infancy), febrile seizure (patient mother had before 12 months old) and tonic-clonic seizures (patient mother managed it with sodium valproate only). On an unknown date, the patient received the 1st dose of DTPa-HBV-IPV-HIB, the 2nd dose of DTPa-HBV-IPV-HIB, the 3rd dose of DTPa-HBV-IPV-HIB, the 1st dose of Rotavirus vaccine, the 2nd dose of Rotavirus vaccine, HIB and Meningitis C vaccine at an unknown dose, MMR vaccine, the 1st dose of 13-VALENT PNEUMOCOCCAL CONJUGATE, the 2nd dose of 13-VALENT PNEUMOCOCCAL CONJUGATE and the 3rd dose of 13-VALENT PNEUMOCOCCAL CONJUGATE. On an unknown date, between 10 and 11 months after receiving DTPa-HBV-IPV-HIB and Rotavirus vaccine, 8 months after receiving DTPa-HBV-IPV-HIB and Rotavirus vaccine, 6 months after receiving DTPa-HBV-IPV-HIB, 27 hrs after receiving HIB and Meningitis C vaccine and MMR vaccine and an unknown time after starting levetiracetam, the patient experienced brain death (serious criteria death and GSK medically significant), cerebral edema (serious criteria death and GSK medically significant), hypoxic-ischemic encephalopathy (serious criteria death and GSK medically significant), brain herniation (serious criteria death and GSK medically significant), pneumonia (serious criteria death, hospitalization and GSK medically significant), enterovirus infection (serious criteria death and GSK medically significant), febrile seizure (serious criteria hospitalization and GSK medically significant), cardiopulmonary arrest (serious criteria hospitalization and GSK medically significant), pulmonary edema (serious criteria hospitalization and GSK medically significant), diabetes insipidus (serious criteria GSK medically significant), staring (serious criteria hospitalization), unresponsive to verbal stimuli (serious criteria hospitalization and GSK medically significant), lip smacking (serious criteria hospitalization and GSK medically significant), tonic clonic movements (serious criteria hospitalization and GSK medically significant), status epilepticus (serious criteria hospitalization and GSK medically significant), hyperglycemia, hyperthermia, hypertension, fever and rhinorrhea. The patient was treated with levetiracetam, midazolam, epinephrine (Adrenalin), morphine and antibiotics nos. On an unknown date, the outcome of the brain death, cerebral edema, hypoxic-ischemic encephalopathy, brain herniation, pneumonia and enterovirus infection were fatal and the outcome of the febrile seizure, cardiopulmonary arrest, pulmonary edema, diabetes insipidus, staring, unresponsive to verbal stimuli, lip smacking, tonic clonic movements, status epilepticus, hyperglycemia, hyperthermia, hypertension and fever were unknown and the outcome of the rhinorrhea was recovered/resolved. The reported cause of death was brain death, cerebral edema, hypoxic-ischemic encephalopathy, brain herniation, pneumonia and enterovirus infection. An autopsy was performed. The reporter considered the brain death, cerebral edema, hypoxic-ischemic encephalopathy, brain herniation, pneumonia, enterovirus infection, febrile seizure, cardiopulmonary arrest, pulmonary edema, diabetes insipidus, staring, unresponsive to verbal stimuli, lip smacking, tonic clonic movements, status epilepticus, hyperglycemia, hyperthermia, hypertension, fever and rhinorrhea to be related to DTPa-HBV-IPV-HIB, DTPa-HBV-IPV-HIB, DTPa-HBV-IPV-HIB, Rotavirus vaccine and Rotavirus vaccine. The reporter considered the brain death, cerebral edema, hypoxic-ischemic encephalopathy, brain herniation, pneumonia, enterovirus infection, febrile seizure, cardiopulmonary arrest, pulmonary edema, diabetes insipidus, staring, unresponsive to verbal stimuli, lip smacking, tonic clonic movements, status epilepticus, hyperglycemia, hyperthermia and hypertension to be related to HIB and Meningitis C vaccine and MMR vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of seizure in a 12-month-old male patient, who was vaccinated with unspecified diphtheria-tetanus-acellular pertussis, Haemophilus influenzae type b, hepatitis B and inactivated polio combination vaccine (DTPa-Hib-HepB-IPV), unspecified rotavirus vaccine, unspecified Haemophilus influenzae type b and meningococcal C conjugate vaccine (Hib-MenC), unspecified measles-mumps-rubella vaccine (MMR) (manufacturer unknown) for prophylaxis. The patient born at full-term via spontaneous vaginal delivery to non-consanguineous parents (first pregnancy via in-vitro fertilisation). The patient was a healthy infant with normal growth and development and no significant medical history aside from omphalitis as a neonate. The patient''s mother had epilepsy from infancy, with her first febrile seizure (FS) before 12 months old. The patient''s mother progressed to have both febrile and afebrile bilateral tonic clonic seizures, but no focal seizures or status epilepticus. Seizures of patient''s mother were managed with sodium valproate only. Seizure frequency decreased from once every two months from infancy to puberty, to being seizure free for 4 years before ceasing medication for 5 years before the patient''s birth. There was no significant neurodevelopmental impact from the seizures, and completed high school studies with no assistance. There was a history of epilepsy in sister of patient''s mother and father of patient''s mother. No family members had prolonged seizures or developmental concerns. No information on patient''s concurrent condition or concomitant medication was provided. On an unspecified date, at the age of 6 weeks and at the age of 4 months, the patient received 1st and 2nd dose of unspecified diphtheria-tetanus-acellular pertussis, Haemophilus influenzae type b, hepatitis B and inactivated polio combination vaccine (DTPa-Hib-HepB-IPV) (administration route and site unspecified; batch number not provided), unspecified rotavirus vaccine (batch number not provided) and unspecified 13-valent pneumococcal conjugate vaccine (PCV13) (administration route and site unspecified; batch number not provided) respectively. On an unspecified date, at the age of 6 months, the patient received 3rd dose of unspecified diphtheria-tetanus-acellular pertussis, Haemophilus influenzae type b, hepatitis B and inactivated polio combination vaccine (DTPa-Hib-HepB-IPV) (administration route and site unspecified; batch number not provided), and unspecified 13-valent pneumococcal conjugate vaccine (PCV13) (administration route and site unspecified; batch number not provided) respectively. The patient had no adverse events following immunisation. On an unspecified date, at the age of 12 months, the patient received unspecified Haemophilus influenzae type b and meningococcal C conjugate vaccine (Hib-MenC), and unspecified measles-mumps-rubella vaccine (MMR). On an unspecified date, at the age of 12 months, an unknown period after the vaccination, the patient had a mild febrile illness with rhinorrhea lasting 1-2 weeks and had been afebrile for 3-4 days at the time of Hib-MenC and MMR vaccinations. Approximately 27 hours later, first seizure occurred. The patient''s mother saw him sitting up in bed on the baby video monitor, and went into the room to find him staring, unresponsive with lip smacking, followed by bilateral tonic clonic movements. Fever to 38.5 degree C was recorded on arrival to emergency. 4 doses of midazolam were given before status epilepticus terminated at approximately 40 min. The patient went into cardiopulmonary arrest during intubation and had 40 min of down time before return of spontaneous circulation on an adrenalin infusion. A loading dose of levetiracetam (30 mg/kg) was given and the patient was transferred to paediatric intensive care unit on morphine and adrenaline infusion. Antibiotics were commenced, cerebrospinal Fluid (CSF) collection was deferred. Computer tomography (CT) brain showed severe global hypoxic ischemic brain injury with cerebral oedema. The admission was complicated by pulmonary oedema, secondary pneumonia, diabetes insipidus, hyperglycaemia, hyperthermia and hypertension. Electroencephalography (EEG) showed electrocerebral silence, and magnetic resonance imaging (MRI) re-demonstrated extensive changes with cerebellar tonsillar herniation and absence of flow in the intracranial arteries on magnetic resonance angiogram (MRA) consistent with brain death; medical support was withdrawn, and the patient died. Autopsy found severe cerebral oedema with diffuse hypoxic ischemic encephalopathy changes and cerebellar tonsillar herniation. There was also extensive bronchopneumonia. Enterovirus 71 was found on tracheal and rectal swab. There were no signs of meningitis or encephalitis on neuropathological exam of brain and spinal cord. Genomic testing was not performed at the time of autopsy. Instead, the patient''s mother was referred for genetic review during her subsequent pregnancy. Whole exome sequencing was arranged on a stored liver-derived DNA sample from the Case, focussing on a panel of SUDEP (sudden unexpected death in epilepsy), long QT syndrome and hypoventilation-associated genes. The detected heterozygous missense variant in SCN1A (NM001165963.1: c.2866AG;p.(Met956Val)) was novel and classified as likely pathogenic by Regulatory Authority guidelines (Class 4: PM2, PM5, PP2, PP3). This variant was also subsequently found in the patient''s mother. This case has been considered serious due to death and hospitalization. The author commented, "SCN1A variants cause a spectrum of epilepsy syndromes from Dravet Syndrome, a severe epileptic encephalopathy of early infancy to the milder disorder of genetic epilepsy with febrile seizures plus (GEFS+). These genetic epilepsies are associated with increased risk of poor outcome including complications of status epilepticus and early mortality. Individualised management of young children known to be at increased risk should be considered, such as around vaccination management. Vaccinations have been implicated in triggering an earlier onset of seizures in children with underlying genetic epilepsy, including SCN1Arelated Dravet syndrome. While this was a novel amino acid change, other pathogenic missense changes affecting the same residue, including p.Met956Thr, have been reported where in vitro studies demonstrate reduced cell surface SCN1A expression, highlighting the functional importance of this particular highly conserved methionine. The absence of variants in this position in population databases including Genome Aggregation Database (gnomAD) and in silico predictions support this missense variant as being likely pathogenic. We report a novel missense SCN1A variant in a 12-month-old child who suffered a catastrophic outcome from status epilepticus with cardiac arrest following vaccination, in the context of recent febrile illness likely associated with enterovirus 71. Multiple factors may have contributed to the death of this Case including vaccination, status epilepticus, pathogenic SCN1A variant and enterovirus infection. Although it is not possible to predict an individual''s phenotype based on their genotype alone, the pattern in this family is more consistent with GEFS plussyndrome, and missense variants more commonly occur with the milder GEFS plus phenotype. Post-vaccination seizures occur in a small number of individuals and are well documented in children with Dravet syndrome. SCN1A variants predispose individuals, particularly those with Dravet syndrome, to status epilepticus and to an increased risk of SUDEP. Enterovirus 71 infection can cause FSs, aseptic meningitis, and encephalitis following a prodromal illness as in this Case and does not typically have evidence of cerebritis at autopsy. The presence of CNS infection was unclear due to lack of CSF sampling in this acutely ill infant. In this case, where cardiac arrest followed status epilepticus, enterovirus 71 also predisposes to pulmonary oedema and myocarditis, with young children more severely affected. Pre-symptomatic treatment is not our standard management of FSs or risk of seizures in families with genetic epilepsy, as antiepileptic medications may be associated with side effects including on neurodevelopment and cognition." The author concluded, "This is the first report of this novel pathogenic SCN1A variant associated with status epilepticus, viral infection and infant death following vaccination. We have described an approach to personalized management around vaccination of an asymptomatic younger sibling with the same variant. Establishing genetic aetiology as early as possible in familial epilepsies has the potential to change management and outcomes for affected children. In future, through cooperative international efforts using well-designed natural history and treatment trials, it should be possible to predict risks and benefits of pre-symptomatic treatment with greater certainty in similar cases, with a view to optimising personalised management of vaccination for children with genetic epilepsies." Lab Comments: Lab test done on an unknown date. Cerebrospinal Fluid (CSF) collection was deferred. Computer tomography (CT) brain showed severe global hypoxic ischemic brain injury with cerebral oedema. Electroencephalography (EEG) showed electrocerebral silence, and magnetic resonance imaging (MRI) re-demonstrated extensive changes with cerebellar tonsillar herniation and absence of flow in the intracranial arteries on magnetic resonance angiogram (MRA) consistent with brain death. Enterovirus 71 was found on tracheal and rectal swab.; Reported Cause(s) of Death: Brain death; Cerebral oedema; Hypoxic-ischemic encephalopathy; Brain herniation; Pneumonia; Enterovirus infection


VAERS ID: 867921 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Corynebacterium test positive, Culture throat positive, Death, Diphtheria, Polymerase chain reaction positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 201703; Test Name: Throat swab; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 201703; Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: JPGLAXOSMITHKLINEVN2020GS

Write-up: Death NOS; Suspected vaccination failure; Diphtheria; This case was reported in a literature article and described the occurrence of unknown cause of death in a 13-year-old male patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis. Co-suspect products included DTP (A or W not known) (DTP (A or W not known)) for prophylaxis and DTP (A or W not known) (DTP (A or W not known)) for prophylaxis. On an unknown date, the patient received the 1st dose of DTP (A or W not known), the 2nd dose of DTP (A or W not known) and the 3rd dose of DTP (A or W not known). On an unknown date, unknown after receiving DTP (A or W not known), DTP (A or W not known) and DTP (A or W not known), the patient experienced unknown cause of death (serious criteria death and GSK medically significant), vaccination failure (serious criteria death and GSK medically significant) and diphtheria (serious criteria GSK medically significant). On an unknown date, the outcome of the unknown cause of death and vaccination failure were fatal and the outcome of the diphtheria was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to DTP (A or W not known), DTP (A or W not known) and DTP (A or W not known). The reporter considered the vaccination failure and diphtheria to be related to DTP (A or W not known), DTP (A or W not known) and DTP (A or W not known). Additional details were provided as follows: This case was reported in a literature article and described the suspected vaccination failure in a 13-year-old male patient, who was vaccinated with unspecified diphtheria-tetanus-pertussis (DTP) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of the study that was conducted during 2015-2018, seven schools in rural country experienced diphtheria outbreaks. [During June 2015-April 2018, the Agency in this country, and the health authority investigated 46 cases involving patients with suspected diphtheria, 8 of whom died, and 49 asymptomatic contacts in the provinces of in the central region of this country]. The patient was a student from primary through high school and live in dormitories during the week. No information on patient''s medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, at the time of infancy or at 1 year of age, the patient received 3 doses of unspecified diphtheria-tetanus-pertussis (DTP) vaccine (administration route and site unspecified; batch number not provided) [In 1981, introduced a vaccination program in which participants received 3 primary doses of DTP (DTP3) vaccine; in 2011, a booster shot (DTP4) to be given 18 months after the initial doses was added. The time of last vaccination was infancy or at 1 year of age according to the vaccination program]. On 15 March 2017, an unknown period after the vaccination, the patient experienced symptoms either fever, or sore throat, or pseudomembrane, or difficulty swallowing, or submandibular lymphadenopathic (LN) swelling. The patient''s throat swab specimens was collected. Sheep blood agar and tellurite medium culture was used to identify Corynebacterium diphtheriae and extracted DNA with a QIAGEN DNA Mini Kit (QIAGEN) following a standard protocol. 2 sets of primers, Tox1/Tox2 and Dipht6F/Dipht6R was used for PCR testing. [The Elek test for diphtheria was not available]. The patient was found positive in both culture and PCR tests and laboratory testing confirmed diphtheria. The culture-positive isolates were biotype mitis. [Biotypes are of Corynebacterium diphtheriae bacteria]. The sequence type (ST) was ST209. This case has been considered as suspected vaccination failure being the time to onset was unknown. On an unspecified date between June 2015 and April 2018, the patient died with an unknown cause. It was unknown whether the patient''s autopsy was performed or not. This case has been considered serious due to death and suspected vaccination failure. The author commented, "After a diphtheria-tetanus-pertussis vaccine (DTP) was introduced in the early 20th century, the number of cases dramatically decreased. Incidence reached a low of 4,333 cases in 2006, but more recently, the number of reported cases has increased, with incidence reaching 16,648 cases in 2018. After January 2017, in each commune, diphtheria clusters formed mainly by school; cases in each school-based cluster shared the same ST. School clusters of the same ST in 2 communes in this District were linked by a student who commuted between the communes. We could not identify any other epidemiologic links between clusters. An epidemic curve showed the ST and outcome of cases by their onset. A long gap between clusters might indicate that the disease was transmitted through asymptomatic or skin carriers. However, further genomic testing is necessary to clarify the transmission pathway. Of 8 persons who died, 3 were vaccinated, 1 each with 2, 3, and 4 doses. However, the vaccination history of 85% of patients was unknown. We compared the ratios of vaccinated and unvaccinated children and found a significantly smaller proportion of children had received DTP3 in the outbreak communes than in non-outbreak communes. It has been predicted that age of diphtheria case-patients could increase after introduction of DTP because a high proportion of older persons will be susceptible to the disease due to reduced circulation of bacteria, especially when no booster dose is provided. In 2013, the health service temporarily suspended DTP immunization during a severe adverse event case investigation, which halved DTP3 coverage in the country and potentially led to outbreaks. Students also share crowded school dormitories, which is a major factor for spreading disease. Moreover, students go home on weekends, increasing the chance of transmission between their schools and homes. Our finding of vaccinated people dying is particularly alarming because it might indicate a waning of vaccine-derived immunity. However, the sensitivity of laboratory testing might have been low because of the length of time required to collect and transport samples or because of prior antimicrobial drug use, so some carriers likely were not identified. Supplemental immunization activities were conducted in the outbreak area and 2 neighboring districts. Healthcare agencies initiated 2 campaigns: the first, targeting persons 5-40 years of age, sought to administer 3 doses of tetanus-diphtheria vaccine and achieved more than 90% coverage. Simultaneously, a second campaign was conducted to administer DPT to previously unvaccinated children 1-4 years of age. However, 1 unvaccinated person with diphtheria and 2 asymptomatic carriers who had received 1 dose of DPT were reported 6 months after the supplemental immunization activity. This finding was probably because diphtheria toxoid vaccine does not prevent transmission but prevents respiratory disease; thus, carriage of the organism persists. The World Health Organization recommends that students receive a booster vaccination when entering school. However, even if this recommendation is adopted, maintaining high uptake of primary and booster doses remains critical." This is 1 of the 6 valid cases reported in the same literature article. Lab Comments: The patient''s throat swab specimens was collected. Sheep blood agar and tellurite medium culture was used to identify Corynebacterium diphtheriae and extracted DNA with a QIAGEN DNA Mini Kit (QIAGEN) following a standard protocol. 2 sets of primers, Tox1/Tox2 and Dipht6F/Dipht6R was used for PCR testing. The sequence type (ST) was ST209.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 867922 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 - / -

Administered by: Other       Purchased by: ?
Symptoms: Corynebacterium test positive, Culture throat positive, Death, Diphtheria, Polymerase chain reaction positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 201704; Test Name: Throat swab; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 201704; Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: JPGLAXOSMITHKLINEVN2020GS

Write-up: Diphtheria; Death NOS; Suspected vaccination failure; This case was reported in a literature article and described the occurrence of unknown cause of death in a 7-year-old male patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis. Co-suspect products included DTP (A or W not known) (DTP (A or W not known)) for prophylaxis, DTP (A or W not known) (DTP (A or W not known)) for prophylaxis and DTP (A or W not known) (DTP (A or W not known)) for prophylaxis. On an unknown date, the patient received the 1st dose of DTP (A or W not known), the 2nd dose of DTP (A or W not known), the 3rd dose of DTP (A or W not known) and the 4th dose of DTP (A or W not known). On an unknown date, unknown after receiving DTP (A or W not known), DTP (A or W not known), DTP (A or W not known) and DTP (A or W not known), the patient experienced unknown cause of death (serious criteria death and GSK medically significant), vaccination failure (serious criteria death and GSK medically significant) and diphtheria (serious criteria GSK medically significant). On an unknown date, the outcome of the unknown cause of death and vaccination failure were fatal and the outcome of the diphtheria was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to DTP (A or W not known), DTP (A or W not known), DTP (A or W not known) and DTP (A or W not known). The reporter considered the vaccination failure and diphtheria to be related to DTP (A or W not known), DTP (A or W not known), DTP (A or W not known) and DTP (A or W not known). Additional details were provided as follows: This case was reported in a literature article and described the suspected vaccination failure in a 7-year-old male patient, who was vaccinated with unspecified diphtheria-tetanus-pertussis (DTP) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of the study that was conducted during 2015-2018, seven schools in this rural country experienced diphtheria outbreaks. [During June 2015-April 2018, the Agency in this country, and the health authority investigated 46 cases involving patients with suspected diphtheria, 8 of whom died, and 49 asymptomatic contacts in the provinces of central regions in this country]. The patient was a student from primary through high school and live in dormitories during the week. No information on patient''s medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, at the time of infancy or at 1 year of age, the patient received 4 doses of unspecified diphtheria-tetanus-pertussis (DTP) vaccine (administration route and site unspecified; batch number not provided). [In 1981, this country introduced a vaccination program in which participants received 3 primary doses of DTP (DTP3) vaccine; in 2011, a booster shot (DTP4) to be given 18 months after the initial doses was added. The time of last vaccination was infancy or at 1 year of age according to the vaccination program]. On 20 April 2017, an unknown period after the vaccination, the patient experienced symptoms either fever, or sore throat, or pseudomembrane, or difficulty swallowing, or submandibular lymphadenopathic (LN) swelling. The patient''s throat swab specimens was collected. Sheep blood agar and tellurite medium culture was used to identify Corynebacterium diphtheriae and extracted DNA with a QIAGEN DNA Mini Kit (QIAGEN) following a standard protocol. 2 sets of primers, Tox1/Tox2 and Dipht6F/Dipht6R was used for PCR testing. [The Elek test for diphtheria was not available]. The patient was found positive in both culture and PCR tests and laboratory testing confirmed diphtheria. The culture-positive isolates were biotype mitis. [Biotypes are of Corynebacterium diphtheriae bacteria]. The sequence type (ST) was ST243. This case has been considered as suspected vaccination failure being the time to onset was unknown. On an unspecified date between June 2015 and April 2018, the patient died with an unknown cause. It was unknown whether the patient''s autopsy was performed or not. This case has been considered serious due to death and suspected vaccination failure. The author commented, "After a diphtheria-tetanus-pertussis vaccine (DTP) was introduced in the early 20th century, the number of cases dramatically decreased. Incidence reached a low of 4,333 cases in 2006, but more recently, the number of reported cases has increased, with incidence reaching 16,648 cases in 2018. After January 2017, in each commune, diphtheria clusters formed mainly by school; cases in each school-based cluster shared the same ST. School clusters of the same ST in 2 communes were linked by a student who commuted between the communes. We could not identify any other epidemiologic links between clusters. An epidemic curve showed the ST and outcome of cases by their onset. A long gap between clusters might indicate that the disease was transmitted through asymptomatic or skin carriers. However, further genomic testing is necessary to clarify the transmission pathway. Of 8 persons who died, 3 were vaccinated, 1 each with 2, 3, and 4 doses. However, the vaccination history of 85% of patients was unknown. We compared the ratios of vaccinated and unvaccinated children and found a significantly smaller proportion of children had received DTP3 in the outbreak communes than in non-outbreak communes. It has been predicted that age of diphtheria case-patients could increase after introduction of DTP because a high proportion of older persons will be susceptible to the disease due to reduced circulation of bacteria, especially when no booster dose is provided. In 2013, the health service temporarily suspended DTP immunization during a severe adverse event case investigation, which halved DTP3 coverage in the country and potentially led to outbreaks. Students also share crowded school dormitories, which is a major factor for spreading disease. Moreover, students go home on weekends, increasing the chance of transmission between their schools and homes. Our finding of vaccinated people dying is particularly alarming because it might indicate a waning of vaccine-derived immunity. However, the sensitivity of laboratory testing might have been low because of the length of time required to collect and transport samples or because of prior antimicrobial drug use, so some carriers likely were not identified. Supplemental immunization activities were conducted in the outbreak area and 2 neighboring districts. Healthcare agencies initiated 2 campaigns: the first, targeting persons 5-40 years of age, sought to administer 3 doses of tetanus-diphtheria vaccine and achieved more than 90% coverage. Simultaneously, a second campaign was conducted to administer DPT to previously unvaccinated children 1-4 years of age. However, 1 unvaccinated person with diphtheria and 2 asymptomatic carriers who had received 1 dose of DPT were reported 6 months after the supplemental immunization activity. This finding was probably because diphtheria toxoid vaccine does not prevent transmission but prevents respiratory disease; thus, carriage of the organism persists. The World Health Organization recommends that students receive a booster vaccination when entering school. However, even if this recommendation is adopted, maintaining high uptake of primary and booster doses remains critical." This is 1 of the 6 valid cases reported in the same literature article. Lab Comments: The patient''s throat swab specimens was collected. Sheep blood agar and tellurite medium culture was used to identify Corynebacterium diphtheriae and extracted DNA with a QIAGEN DNA Mini Kit (QIAGEN) following a standard protocol. 2 sets of primers, Tox1/Tox2 and Dipht6F/Dipht6R was used for PCR testing. The sequence type (ST) was ST243.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 867923 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Corynebacterium test positive, Death, Diphtheria, Dysphagia, Oropharyngeal pain, Polymerase chain reaction positive, Pyrexia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 201705; Test Name: Throat swab; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 201705; Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: JPGLAXOSMITHKLINEVN2020GS

Write-up: Death NOS; Suspected vaccination failure; Diphtheria; This case was reported in a literature article and described the occurrence of unknown cause of death in a 10-year-old male patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis. Co-suspect products included DTP (A or W not known) (DTP (A or W not known)) for prophylaxis and DTP (A or W not known) (DTP (A or W not known)) for prophylaxis. On an unknown date, the patient received the 1st dose of DTP (A or W not known), the 2nd dose of DTP (A or W not known) and the 3rd dose of DTP (A or W not known). On an unknown date, unknown after receiving DTP (A or W not known), DTP (A or W not known) and DTP (A or W not known), the patient experienced unknown cause of death (serious criteria death and GSK medically significant), vaccination failure (serious criteria death and GSK medically significant) and diphtheria (serious criteria GSK medically significant). On an unknown date, the outcome of the unknown cause of death and vaccination failure were fatal and the outcome of the diphtheria was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to DTP (A or W not known), DTP (A or W not known) and DTP (A or W not known). The reporter considered the vaccination failure and diphtheria to be related to DTP (A or W not known), DTP (A or W not known) and DTP (A or W not known). Additional details were provided as follows: This case was reported in a literature article and described the suspected vaccination failure in a 10-year-old male patient, who was vaccinated with unspecified diphtheria-tetanus-pertussis (DTP) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of the study that was conducted during 2015-2018, seven schools in this rural country experienced diphtheria outbreaks. [During June 2015-April 2018, the Agency in this country, and the health authority investigated 46 cases involving patients with suspected diphtheria, 8 of whom died, and 49 asymptomatic contacts in the provinces of the central regions of this country]. The patient was a student from primary through high school and live in dormitories during the week. No information on patient''s medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, at the time of infancy or at 1 year of age, the patient received 3 doses of unspecified diphtheria-tetanus-pertussis (DTP) vaccine (administration route and site unspecified; batch number not provided). [In 1981, this country introduced a vaccination program in which participants received 3 primary doses of DTP (DTP3) vaccine; in 2011, a booster shot (DTP4) to be given 18 months after the initial doses was added. The time of last vaccination was infancy or at 1 year of age according to the vaccination program]. On 20 May 2017, an unknown period after the vaccination, the patient experienced symptoms either fever, or sore throat, or pseudomembrane, or difficulty swallowing, or submandibular lymphadenopathic (LN) swelling. The patient''s throat swab specimens was collected. Sheep blood agar and tellurite medium culture was used to identify Corynebacterium diphtheriae and extracted DNA with a QIAGEN DNA Mini Kit (QIAGEN) following a standard protocol. 2 sets of primers, Tox1/Tox2 and Dipht6F/Dipht6R was used for PCR testing. [The Elek test for diphtheria was not available]. The patient was found positive in both culture and PCR tests and laboratory testing confirmed diphtheria. The culture-positive isolates were biotype mitis. [Biotypes are of Corynebacterium diphtheriae bacteria]. The sequence type (ST) was ST243. This case was epidemiologically linked asymptomatic carriers from secondary school. This case has been considered as suspected vaccination failure being the time to onset was unknown. This case has been considered serious due to suspected vaccination failure. The author commented, "After a diphtheria-tetanus-pertussis vaccine (DTP) was introduced in the early 20th century, the number of cases dramatically decreased. Incidence reached a low of 4,333 cases in 2006, but more recently, the number of reported cases has increased, with incidence reaching 16,648 cases in 2018. After January 2017, in each commune, diphtheria clusters formed mainly by school; cases in each school-based cluster shared the same ST. School clusters of the same ST in 2 communes were linked by a student who commuted between the communes. We could not identify any other epidemiologic links between clusters. An epidemic curve showed the ST and outcome of cases by their onset. A long gap between clusters might indicate that the disease was transmitted through asymptomatic or skin carriers. However, further genomic testing is necessary to clarify the transmission pathway. Of 8 persons who died, 3 were vaccinated, 1 each with 2, 3, and 4 doses. However, the vaccination history of 85% of patients was unknown. We compared the ratios of vaccinated and unvaccinated children and found a significantly smaller proportion of children had received DTP3 in the outbreak communes than in non-outbreak communes. It has been predicted that age of diphtheria case-patients could increase after introduction of DTP because a high proportion of older persons will be susceptible to the disease due to reduced circulation of bacteria, especially when no booster dose is provided. In 2013, the health service temporarily suspended DTP immunization during a severe adverse event case investigation, which halved DTP3 coverage in the country and potentially led to outbreaks. Students also share crowded school dormitories, which is a major factor for spreading disease. Moreover, students go home on weekends, increasing the chance of transmission between their schools and homes. Our finding of vaccinated people dying is particularly alarming because it might indicate a waning of vaccine-derived immunity. However, the sensitivity of laboratory testing might have been low because of the length of time required to collect and transport samples or because of prior antimicrobial drug use, so some carriers likely were not identified. Supplemental immunization activities were conducted in the outbreak area and 2 neighboring districts. Healthcare agencies initiated 2 campaigns: the first, targeting persons 5-40 years of age, sought to administer 3 doses of tetanus-diphtheria vaccine and achieved more than 90% coverage. Simultaneously, a second campaign was conducted to administer DPT to previously unvaccinated children 1-4 years of age. However, 1 unvaccinated person with diphtheria and 2 asymptomatic carriers who had received 1 dose of DPT were reported 6 months after the supplemental immunization activity. This finding was probably because diphtheria toxoid vaccine does not prevent transmission but prevents respiratory disease; thus, carriage of the organism persists. The World Health Organization recommends that students receive a booster vaccination when entering school. However, even if this recommendation is adopted, maintaining high uptake of primary and booster doses remains critical." This is 1 of the 6 valid cases reported in the same literature article. Lab Comments: The patient''s throat swab specimens was collected. Sheep blood agar and tellurite medium culture was used to identify Corynebacterium diphtheriae and extracted DNA with a QIAGEN DNA Mini Kit (QIAGEN) following a standard protocol. 2 sets of primers, Tox1/Tox2 and Dipht6F/Dipht6R was used for PCR testing. The sequence type (ST) was ST243.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 867924 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Corynebacterium test positive, Culture throat positive, Death, Diphtheria, Polymerase chain reaction positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20180417; Test Name: Throat swab; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 20180417; Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown
CDC Split Type: JPGLAXOSMITHKLINEVN2020GS

Write-up: Death NOS; Diphtheria; This case was reported in a literature article and described the occurrence of unknown cause of death in a 4-year-old male patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis. Previously administered products included DTP (A or W not known) (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of DTP (A or W not known). On an unknown date, unknown after receiving DTP (A or W not known), the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and diphtheria (serious criteria GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the diphtheria was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to DTP (A or W not known). The reporter considered the diphtheria to be related to DTP (A or W not known). Additional details were provided as follows: This case was reported in a literature article and described the occurrence of diphtheria in a 4-year-old male patient, who was vaccinated with unspecified diphtheria-tetanus-pertussis (DTP) vaccine (manufacturer unknown) for prophylaxis. The patient was a part of the study that was conducted during 2015-2018, seven schools in this rural country experienced diphtheria outbreaks. [During June 2015-April 2018, the Agency in this country, and the health authority investigated 46 cases involving patients with suspected diphtheria, 8 of whom died, and 49 asymptomatic contacts in the provinces of the central regions of this country]. The patient was a student from primary through high school and live in dormitories during the week. No information on patient''s medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, at the time of infancy or at 1 year of age, the patient received 2 doses of unspecified diphtheria-tetanus-pertussis (DTP) vaccine (administration route and site unspecified; batch number not provided). [In 1981, this country introduced a vaccination program in which participants received 3 primary doses of DTP (DTP3) vaccine; in 2011, a booster shot (DTP4) to be given 18 months after the initial doses was added. The time of last vaccination was infancy or at 1 year of age according to the vaccination program]. On 17 April 2018, an unknown period after the vaccination, the patient experienced symptoms either fever, or sore throat, or pseudomembrane, or difficulty swallowing, or submandibular lymphadenopathic (LN) swelling. The patient''s throat swab specimens was collected. Sheep blood agar and tellurite medium culture was used to identify Corynebacterium diphtheriae and extracted DNA with a QIAGEN DNA Mini Kit (QIAGEN) following a standard protocol. 2 sets of primers, Tox1/Tox2 and Dipht6F/Dipht6R was used for PCR testing. [The Elek test for diphtheria was not available]. The patient was found positive only in PCR test and found negative in culture test. The laboratory testing confirmed diphtheria. The culture isolates were biotype intermed. [Biotypes are of Corynebacterium diphtheriae bacteria]. The sequence type (ST) was ST67. This case was epidemiologically linked asymptomatic carriers from nursery school. On an unspecified date between June 2015 and April 2018, the patient died with an unknown cause. It was unknown whether the patient''s autopsy was performed or not. This case has been considered serious due to death. The author commented, "After a diphtheria-tetanus-pertussis vaccine (DTP) was introduced in the early 20th century, the number of cases dramatically decreased. Incidence reached a low of 4,333 cases in 2006, but more recently, the number of reported cases has increased, with incidence reaching 16,648 cases in 2018. After January 2017, in each commune, diphtheria clusters formed mainly by school; cases in each school-based cluster shared the same ST. School clusters of the same ST in 2 communes were linked by a student who commuted between the communes. We could not identify any other epidemiologic links between clusters. An epidemic curve showed the ST and outcome of cases by their onset. A long gap between clusters might indicate that the disease was transmitted through asymptomatic or skin carriers. However, further genomic testing is necessary to clarify the transmission pathway. Of 8 persons who died, 3 were vaccinated, 1 each with 2, 3, and 4 doses. However, the vaccination history of 85% of patients was unknown. We compared the ratios of vaccinated and unvaccinated children and found a significantly smaller proportion of children had received DTP3 in the outbreak communes than in non-outbreak communes. It has been predicted that age of diphtheria case-patients could increase after introduction of DTP because a high proportion of older persons will be susceptible to the disease due to reduced circulation of bacteria, especially when no booster dose is provided. In 2013, the health service temporarily suspended DTP immunization during a severe adverse event case investigation, which halved DTP3 coverage in the country and potentially led to outbreaks. Students also share crowded school dormitories, which is a major factor for spreading disease. Moreover, students go home on weekends, increasing the chance of transmission between their schools and homes. Our finding of vaccinated people dying is particularly alarming because it might indicate a waning of vaccine-derived immunity. However, the sensitivity of laboratory testing might have been low because of the length of time required to collect and transport samples or because of prior antimicrobial drug use, so some carriers likely were not identified. Supplemental immunization activities were conducted in the outbreak area and 2 neighboring districts. Healthcare agencies initiated 2 campaigns: the first, targeting persons 5-40 years of age, sought to administer 3 doses of tetanus-diphtheria vaccine and achieved more than 90% coverage. Simultaneously, a second campaign was conducted to administer DPT to previously unvaccinated children 1-4 years of age. However, 1 unvaccinated person with diphtheria and 2 asymptomatic carriers who had received 1 dose of DPT were reported 6 months after the supplemental immunization activity. This finding was probably because diphtheria toxoid vaccine does not prevent transmission but prevents respiratory disease; thus, carriage of the organism persists. The World Health Organization recommends that students receive a booster vaccination when entering school. However, even if this recommendation is adopted, maintaining high uptake of primary and booster doses remains critical." This is 1 of the 6 valid cases reported in the same literature article. Lab Comments: The patient''s throat swab specimens was collected. Sheep blood agar and tellurite medium culture was used to identify Corynebacterium diphtheriae and extracted DNA with a QIAGEN DNA Mini Kit (QIAGEN) following a standard protocol. 2 sets of primers, Tox1/Tox2 and Dipht6F/Dipht6R was used for PCR testing. The patient was found positive only in PCR test and found negative in culture test. The laboratory testing confirmed diphtheria. The culture isolates were biotype intermed. [Biotypes are of Corynebacterium diphtheriae bacteria]. The sequence type (ST) was ST67.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 868926 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Cardiac arrest, Computerised tomogram neck, Cyanosis, Death, Depressed level of consciousness, Dysphonia, Dyspnoea, Endotracheal intubation, Foaming at mouth, Hyperaemia, Mechanical ventilation, Myalgia, Odynophagia, Poor peripheral circulation, Pyrexia, Respiratory arrest, Resuscitation, Speech disorder, Streptococcus test negative, Stridor, Tonsillitis, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Agranulocytosis (broad), Angioedema (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Convulsions (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT-cervical; Result Unstructured Data: There was edema along the visceral compartment, both in the retropharyngeal space and in the pre-tracheal space which obliterated the airways and digestive tract.; Test Name: Streptococcus A; Test Result: Negative
CDC Split Type: PTSA2020SA102639

Write-up: Acute respiratory failure; stridor to pulmonary auscultation; respiratory arrest; rapid degradation of the state of consciousness; odynophagia; difficulty in speaking; dyspnea, worsening of breathing difficulties; a hoarse voice; emission of foaming hematic secretions from the mouth and nose; cardiac arrest; cyanosis; myalgia; poor peripheral perfusion; hyperemia; tonsillitis; fever, feverish; Serotyping at INSA confirmed Hib; Initial information was received on 19-Apr-2020 regarding an unsolicited valid serious case issued from a literature article. This case involves a 14 years old male patient who experienced acute respiratory failure (acute respiratory failure), cardiac arrest (cardiac arrest), myalgia (myalgia), poor peripheral perfusion (poor peripheral circulation), hyperemia (hyperaemia), tonsillitis (tonsillitis), fever, feverish (pyrexia) and reported vaccination failure, while he received vaccine HAEMOPHILUS TYPE B (HIB) VACCINE. Past medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer (lot number and other dosing details were not reported) for prophylactic vaccination. On an unknown date, the patient developed a serious acute respiratory failure with the symptoms stridor to pulmonary auscultation (stridor), respiratory arrest, rapid degradation of the state of consciousness (depressed level of consciousness), odynophagia, difficulty in speaking (speech disorder), dyspnea, worsening of breathing difficulties (dyspnoea), hoarse voice (dysphonia) and emission of foaming hematic secretions from the mouth and nose (foaming at mouth), unknown latency following the administration of HAEMOPHILUS TYPE B (HIB) VACCINE. These events were assessed as medically significant and were leading to death. The patient was hospitalized for these events. On an unkwnon date, the patient developed a serious cardiac arrest with cyanosis, unknown latency following the administration of HAEMOPHILUS TYPE B (HIB) VACCINE. These events were assessed as medically significant and were leading to death. The patient was hospitalized for these events On an unkwnon date, the patient developed a serious myalgia, poor peripheral perfusion (poor peripheral circulation), hyperemia (hyperaemia), tonsillitis and fever, feverish (pyrexia), unknown latency following the administration of HAEMOPHILUS TYPE B (HIB) VACCINE. These events were leading to death. The patient was hospitalized for these events. This was also a case of vaccination failure as serotyping at laboratory confirmed HIB. Case Description: Despite the excellent immunogenicity of Haemophilus influenzae type B (Hib) vaccine, rare cases of infection are still described. A 14-year-old-male adolescent comes to pediatric emergency due to fever, myalgia, and odynophagia after one day of evolution and progressive worsening. The national vaccination program was performed. At admission, he was feverish, had poor peripheral perfusion, complaining, hyperemia tonsillitis. Research on Streptococcus A was negative. There was clinical worsening with moderate dyspnea, difficulty in speaking, a hoarse voice, and stridor to pulmonary auscultation. The diagnostic hypothesis of epiglottis versus bacterial laryngotracheitis was defined. In the treatment room, when he was prepared for the administration of medication, there was a sudden worsening of breathing difficulties, cyanosis, and emission of foaming hematic secretions from the mouth and nose. There was rapid degradation of the state of consciousness, followed by respiratory and cardiac arrest: early intubation, initiating mechanical ventilation, and successful cardiovascular resuscitation maneuvers. There was no response to ventilation with mask and ambu, he responded to mechanical ventilation with aggressive parameters. CT-cervical: "There was edema along the visceral compartment, both in the retropharyngeal space and in the pre-tracheal space which obliterated the airways and digestive tract. Serotyping at laboratory confirmed Hib. Declared death after 72 hours of the onset of symptoms. Relevant laboratory test results included: On an unknown date, cervical computerized tomogram performed and there was edema along the visceral compartment, both in the retropharyngeal space and in the pre-tracheal space which obliterated the airways and digestive tract and streptococcus test was negative. Final diagnosis were acute respiratory failure, cardiac arrest, myalgia, poor peripheral circulation, hyperaemia, tonsillitis, pyrexia and vaccination failure. It was not reported if the patient received any corrective treatment. On an unknown date, the patient declared death after 72 hours of the onset of symptoms. It was unknown if an autopsy was done. The cause of death was not reported at the time of reporting. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a 14 year old patient who presented with acute respiratory failure, stridor, respiratory arrest, depressed level of consciousness, cardiac arrest, odynophagia ,speech disorder, myalgia, dyspnoea , pyrexia , poor peripheral circulation , hyperaemia , tonsillitis, dysphonia , foaming at mouth, cyanosis and died, despite vaccination with HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer. The time to onset is unknown. Vaccination failure was reported as the laboratory data confirmed the Hemophilus type b. However, patient''s medical condition at the time of vaccination, past vaccinations and autopsy information not reported. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Acute respiratory failure; cardiac arrest; myalgia; poor peripheral circulation; hyperaemia; tonsillitis; pyrexia; vaccination failure


VAERS ID: 869005 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-03-13
Onset:2020-03-01
Submitted: 0000-00-00
Entered: 2020-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B328DD / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine increased, Death, Headache, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-17
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BECOZYME
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy (allergies to almonds); Nonsmoker
Allergies:
Diagnostic Lab Data: Test Date: 20200225; Test Name: Creatinine; Result Unstructured Data: Test Result: 79, Test Result Unit: unknown
CDC Split Type: CHGLAXOSMITHKLINECH202006

Write-up: Headache; Nausea; Tod; This case was reported by a physician via regulatory authority and described the occurrence of unknown cause of death in a 71-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number AC37B328DD, expiry date unknown) for prophylaxis. Previously administered products included Focetria (swine flu vaccine received in Oct 2009) and Boostrix (received In 2013). Concurrent medical conditions included nonsmoker and food allergy (allergies to almonds). Additional patient notes included no liver nor kidney disease. Concomitant products included vitamin B substances nos (Becozyme). On 13th March 2020 09:40, the patient received Boostrix (intramuscular). On 14th March 2020, 1 days after receiving Boostrix, the patient experienced headache and nausea. On 17th March 2020 11:00, 4 days 1 hr 20 min after receiving Boostrix, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On 17th March 2020, the outcome of the unknown cause of death was fatal. On an unknown date, the outcome of the headache and nausea were unknown. The patient died on 17th March 2020. The reported cause of death was death nos. An autopsy was not performed. The reporter considered the unknown cause of death, headache and nausea to be possibly related to Boostrix. Additional details: The age at vaccination was not provided but the patient could be 71 or less than 72 years old. On 25th February 2020, lab test included creatinine with result 79. The patients initials were reported. Boostrix Other assessment as per WHO showed possible to headache, nausea and death. Note the outcome of event nausea headache was reported as fatal, However was captured it as unknown as the cause of death was unknown. The onset date for Headache was reported as 17th March per as per narrative the patient experienced headache on 14th March 2020. Initial information was reported by a Physician via regulatory authority on 20th April 2020: The 72-year-old patient (weight: 73 kg) received an intramuscular booster vaccination with Boostrix (diphtheria / tetanus / pertussis vaccine; lot no.AC37B328DD) on March 13, 2020 at 9:40 a.m. The patient wished for this vaccination if the daughter-in-law had advanced pregnancy, although the last Boostrix vaccination was only in 2013. On March 14, March 15 and March 17, 2020 there was a brief headache and nausea in the morning. Neither vomiting nor fever occurred. No painkillers were taken. On March 17th, 2020 the patient was found dead by his wife. At 11:00 am, 144 and medical stopped the resuscitation. No autopsy was carried out. The patient also took Becozym forte (vitamins of the B complex) once a day. There was neither liver nor kidney disease (creatinine 2/25/2020: 79). The patient had allergies to almonds and a Focetria? vaccine (swine flu) in October 2009. The patient was a non-smoker. We have no further information on this case. Senders comment: The drug information from Boostrix ((diphtheria / tetanus / pertussis vaccine) describes the occurrence of headache as very common (17.7%) and nausea as common (1-10%) UAW. A fatal outcome after vaccination or the lethal outcome is not explicitly listed as UAW. According to the drug information from Becozym, headaches can occur with the B vitamin preparation without specifying the frequency. Since 2004, the WHO pharmacovigilance database lists a total of 20,649 individual case safety reports on Boostrix, 19 cases of "death", most of which were children. There is a temporal relationship between the use of Boostrix and the occurrence of headache, nausea with fatal outcome. A de-challenge cannot be assessed for the lethal outcome. Other causes of death such as B. Cerebral bleeding events with headache and nausea as possible indicative symptoms cannot be excluded. If the autopsy is not carried out, the etiology of the fatal outcome after vaccination has not been definitively clarified. In summary, we assess the causality between the use of Boostrix and the occurrence of headache, nausea with fatal outcome according to the WHO / based on the temporal relationship, the documentation in the drug information and in the databases, but possible other, non-excluded, non-medicinal causes. Regulatory Authority criteria formally possible.; Reported Cause(s) of Death: Death NOS


VAERS ID: 869048 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2020-04-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH CD5398AR7666 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cyanosis, Death, Hypopnoea, Lip dry, Peripheral coldness, Resuscitation, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-04-17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Volvulus of bowel
Allergies:
Diagnostic Lab Data: Test Date: 20200417; Test Name: breathing; Result Unstructured Data: Test Result:weak
CDC Split Type: CNPFIZERINC2020160118

Write-up: the patient died; Lips cyanosed; Cold hands and feet; lips were dry; breathing was weak; This is a spontaneous report from a contactable physician via sales representatives. An approximately 5-month-old male patient received third dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, lot number: CD5398AR7666), via an unspecified route of administration on 17Apr2020 at a single dose for immunization. The patient''s medical history included the patient received volvulus of bowel on the ninth day of birth. Concomitant medications included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 2-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PENTAVAC) on 06Apr2020 for immunization and there were no adverse events. The patient previously took first and second dose of pneumococcal 13-val conj vac (dipht crm197 protein) for immunization. At 13:30 on 17Apr2020, the parents soaked 150 milliliters of milk powder, the child only ate 50 milliliters of milk powder (the patient can finish eating 150 milliliters normally), and the child normally took a quiet time in the afternoon. However, the parents did not sleep well during the afternoon, the temperature of the patient was more than 36 degrees, after the patient had finished drinking milk and sleeping, the look of the patient was not good at about 16:00. On 17Apr2020, the lips were dry, the hands and feet were cold, the temperature was more than 36 degrees again, then the patient were sent to the hospital at more than 17:00. On 17Apr2020, the patient also developed lips cyanosed. When the road was blocked, the breathing was weak, the face was purple, and the patient were rushed to the hospital emergency room around 19:00. The parents insisted that the hospital continued to rescue, and the hospital heartbeat was continued until 21:00, and the doctor was confirmed that the patient died at about 22:00. The outcome of the other events was unknown. There was no autopsy at the reporting time. The parents were preparing for an autopsy. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The event death is assessed as related to pneumococcal 13-valent 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: the patient died


VAERS ID: 869137 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Autologous haematopoietic stem cell transplant, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood test, CD4 lymphocytes, CD8 lymphocytes, Coma, Combined immunodeficiency, Condition aggravated, Cytogenetic analysis abnormal, Death, Infection, Leukocytosis, Lymphopenia, Natural killer cell count, Subacute sclerosing panencephalitis, T-lymphocyte count increased, Transplant failure, White blood cell count, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Congenital, familial and genetic disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Parental consanguinity; Severe combined immunodeficiency syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: IgA; Test Result: 37 mg/dl; Test Name: IgG; Test Result: 552 mg/dl; Test Name: IgM; Test Result: 29 mg/dl
CDC Split Type: IL0095075132004ISR004543

Write-up: measles encephalitis; This literature marketed report has been received from authors of the published article referring to a 19 months old female patient. The patient had parental consanguinity and had severe combined immunodeficiency (SCID) which was a family history of immunodeficiency. Information about concomitant medication was not provided. On an unknown date (reported as "at the age of 1 year"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) for prophylaxis (strength, dose, frequency, route, lot# and expiration date were not provided). When the patient was 12 months old, she presented with a "leaky" SCID phenotype, displaying higher CD3 counts and later onset infections. Genetic analysis showed RAG2 missense mutations: c.G218A; p.R73H. Laboratory findings were as follow: white blood cell (WBC): 5.2x10^3/micro-l (K/micro-l), polymorphonuclear leukocytosis (PMN): 1.7 K/micro-l; lymphopenia (LYM): 2.1 K/micro-l; immunoglobulin G (IgG): 552 mg/dl; immunoglobulin A (IgA): 37 mg/dl; immunoglobulin M (IgM): 29 mg/dl; CD3/mm3: 636 (units not provided); CD4/mm3: 264 (units not provided); CD8/mm3: 360 (units not provided); CD20/mm3: 1 (units not provided); NK/mm3: 468 (units not provided); T cell receptor excision circles (TREC): 0; T cell receptor (TCR V) beta repertoire showed Restricted/skewed. Mitogen proliferation assays showed normal. On an unknown date, about a year later the patient presented with late onset vaccine strain-derived measles encephalitis with unfortunate devastating clinical outcome-a comatose state. On an unknown date, the patient underwent hematopoietic stem cell transplantation (HSCT) which was merely a salvage therapy. The patient received HSCT with no conditioning had a primary graft failure and passed away soon after the procedure. The reporter considered a rare measles vaccine-derived encephalitis led to the fatal end of the patient. It was unknown if the autopsy was done. Literature Report:. Upon internal review, measles encephalitis was determined to be medically significant. A copy of the published article is attached as further documentation of the patient''s experience.; Reported Cause(s) of Death: measles encephalitis


VAERS ID: 869138 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Exposure during pregnancy, Stillbirth
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INGLAXOSMITHKLINEIN2019AP

Write-up: Intrauterine Fetal Death; Foetal exposure during pregnancy; This retrospective pregnancy case was reported by a physician and described the occurrence of stillbirth in a foetus exposed to DTPa (Reduced antigen) (Boostrix) in utero. The mother received the product for prophylaxis. On an unknown date, the mother received Boostrix. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The foetus was exposed to Boostrix at week 32 of gestation. The foetus was diagnosed with stillbirth (serious criteria death and GSK medically significant) and fetal exposure during pregnancy. On an unknown date, the outcome of the stillbirth was fatal and the outcome of the fetal exposure during pregnancy was unknown. The reported cause of death was stillbirth. It was unknown if the reporter considered the stillbirth to be related to Boostrix. See case IN2019GSK104342 for details regarding the mother case. Additional details were provided as follows: The age at vaccination was not applicable for this report. Three weeks after vaccination, the patient had intrauterine death (IUFD), cause was unknown. This incident happened about 2 to 3 months before the date of reporting and the gynecologist did not remember any other details. No other information was available at the time of reporting.; Reported Cause(s) of Death: Stiillbirth


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.


VAERS ID: 869683 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage foetal, Exposure during pregnancy, Stillbirth
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUSA2020SA103823

Write-up: child in womb has brain hemorrhage and was stillborn; Drug exposure in utero; Upon second medical examination of the case during internal review, a significant correction was performed on 30-Apr-2020 to update the as reported term from child in womb has brain hemorrhage to child in womb has brain hemorrhage and was stillborn and to add seriousness criterion death. Initial information was received on 20-Apr-2020 regarding an unsolicited valid serious case received from a consumer/ non-healthcare professional. This case is linked to case 2020SA103783 (mother case). This case involves fetus patient in womb who had brain hemorrhage and was stillborn (cerebral haemorrhage foetal), while in utero got exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Drug exposure in utero). Medical history, concomitant therapy, medical treatment(s), vaccination(s) were not provided. Patient''s mother details: The mother''s age was not reported at the time of report. The date of last menstrual period and estimated due date were not reported. The actual date of delivery was not reported. On an unknown date, the fetus in utero got exposed to a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported and expiry date 21-Apr-2020) via transplacental route while the mother of patient received a dose of suspect via unknown route of administration in an unknown administration site for prophylactic vaccination. On an unknown date, the child in womb developed a serious brain hemorrhage was still born (cerebral haemorrhage foetal) on an unknown latency following the exposure of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant and was leading to death. The mother of patient stated that she had severe reactions two to four weeks ago and the child in her womb had brain hemorrhage after that. No laboratory data has performed. Final diagnosis was fatal Cerebral haemorrhage foetal. It was not reported if the patient (child in womb) received a corrective treatment. At the time of reporting,outcome was fatal for the event Cerebral haemorrhage foetal. It was unknown if an autopsy was done. The cause of death was reported as Cerebral haemorrhage foetal. There will be no information available on the batch number for this case. Follow-up information was received on 20-Apr-2020 regarding an unsolicited valid serious case received from a consumer/ non-healthcare professional. No new information was received. Addendum: significant correction was performed on 30-Apr-2020 to update the as reported term from child in womb has brain hemorrhage to child in womb has brain hemorrhage and was stillborn and to add seriousness criterion death.; Sender''s Comments: Follow-up information was received on 20-Apr-2020 change the assessment of the case. This case concerns fetus in womb who died due to serious cerebral hemorrhage fetal while got exposed to ADACEL vaccine in utero due to maternal use of vaccine. The trimester of pregnancy at vaccination and time to onset were unknown. Mother''s Medical condition at time of vaccination, her medical and obstetric history, possible risk factors and lab test ruling out alternate etiologies were not reported. It is unknown if autopsy was performed. There might be multiple reasons for fetal cerebral damage. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: Cerebral haemorrhage foetal


VAERS ID: 869747 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-09-30
Onset:2020-02-17
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2020-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER AFLBA376BA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza, Superinfection bacterial, Vaccine breakthrough infection
SMQs:, Infective pneumonia (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease; Essential hypertension (Benign); Obstructive bronchitis; Osteoporosis; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE2020GS

Write-up: Vaccine breakthrough infection/ Vaccination failure; Influenza; Superinfection bacterial; This case was reported by a physician via regulatory authority and described the occurrence of vaccine breakthrough infection in a 70-year-old female patient who received Flu Seasonal QIV Dresden (Influsplit Tetra 2019/2020) (batch number AFLBA376BA, expiry date unknown) for prophylaxis. Concurrent medical conditions included type ii diabetes mellitus, obstructive bronchitis, osteoporosis, chronic obstructive pulmonary disease and essential hypertension (Benign). On 30th September 2019, the patient received Influsplit Tetra 2019/2020 (intramuscular). On 17th February 2020, 140 days after receiving Influsplit Tetra 2019/2020, the patient experienced vaccine breakthrough infection (serious criteria death, hospitalization and GSK medically significant), influenza (serious criteria death and hospitalization) and superinfection bacterial (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccine breakthrough infection, influenza and superinfection bacterial were fatal. The reported cause of death was influenza, vaccine breakthrough infection and superinfection bacterial. It was unknown if the reporter considered the vaccine breakthrough infection, influenza and superinfection bacterial to be related to Influsplit Tetra 2019/2020. Additional details: The age at vaccination was not provided but the patient could be 70 years or less than 70 year old. As per the confirmation received, event- vaccine breakthrough infection was considered as vaccination failure and influenza as that of target disease. More information about the same, if any, is expected in follow up. Initial information was reported by a Physician via regulatory authority on 27th April 2020: influenza, vaccine breakthrough infection and superinfection bacterial.; Reported Cause(s) of Death: Influenza; Vaccine breakthrough infection; Superinfection bacterial


VAERS ID: 869880 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:2018-05-04
Onset:2018-05-01
Submitted: 0000-00-00
Entered: 2020-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aggression, Areflexia, Autophobia, Brain oedema, Chills, Computerised tomogram head abnormal, Cytomegalovirus test negative, Death, Dengue virus test negative, Diarrhoea, Encephalitis, Endotracheal intubation, Epstein-Barr virus antibody negative, Faeces soft, Febrile convulsion, Flavivirus test negative, Lethargy, Mucous stools, Musculoskeletal stiffness, Polymerase chain reaction, Pyrexia, Respiratory failure, Seizure, Skin induration, Skin striae, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Hostility/aggression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (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? Yes
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Dipirone; Ibuprofen
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 201805; Test Name: IgG; Result Unstructured Data: Test Result: not reactive, Test Result Unit: unknown; Test Date: 201805; Test Name: IgM; Result Unstructured Data: Test Result: Epstein Barr non reactive, Test Result Unit: unknown; Test Date: 20180508; Test Name: Body temperature; Result Unstructured Data: Test Result: 40, Test Result Unit: degree C; Test Date: 201805; Test Name: Body temperature; Result Unstructured Data: Test Result: increased, Test Result Unit: degree C; Test Date: 201805; Test Name: Computerized tomogram; Result Unstructured Data: Test Result: difuse cerebral edema, Test Result Unit: unknown; Test Date: 201805; Test Name: Cytomegalovirus test; Result Unstructured Data: Test Result: IGG not reactive 48.2, Test Result Unit: unknown; Test Date: 201805; Test Name: PCR; Result Unstructured Data: Test Result: not dectable, Test Result Unit: unknown
CDC Split Type: BRGLAXOSMITHKLINEBR2020AM

Write-up: Meningoencephalitis; stayed stretching; hard foot; Lethargy; WITHOUT REFLEXES; vomiting; stretching, writhing; hitting her / himself and with hard foot; febrile convulsion; Fever; chills; stayed hitting her/himself/stayed writhing; Diarrhea; softened stools; evacuation of stools with mucus; difuse cerebral edema; RESPIRATORY INSUFFICIENCY; Death; This case was reported by a other health professional via regulatory authority and described the occurrence of death in a 1-year-old female patient who received Men C NVS (Menjugate Liquid) (batch number 162001, expiry date unknown) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis, TRIPLE VIRAL VACCINE (batch number 013N6095A, expiry date unknown) for prophylaxis, dipyrone (Dipirone) unknown for an unknown indication and ibuprofen unknown for fever. Concurrent medical conditions included breast feeding. On 13th April 2018, the patient received the 1st dose of Menjugate Liquid. On 4th May 2018, the patient received the 1st dose of Influenza vaccine Quadrivalent 2018-2019 season. On 13th April 2018, the patient received the 1st dose of TRIPLE VIRAL VACCINE. On 8th May 2018, the patient started Dipirone at an unknown dose and frequency and ibuprofen at an unknown dose and frequency. On 3rd May 2018, 20 days after receiving Menjugate Liquid, 364 days after receiving Influenza vaccine Quadrivalent 2018-2019 season, not applicable after starting Dipirone and ibuprofen and an unknown time after starting diazepam, the patient experienced diarrhea (serious criteria hospitalization) and soft stools (serious criteria hospitalization). On 8th May 2018, the patient experienced febrile convulsion (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization), chills (serious criteria hospitalization) and self hatred (serious criteria hospitalization). In May 2018, the patient experienced cerebral edema (serious criteria hospitalization and GSK medically significant) and mucus stools (serious criteria hospitalization). On 21st May 2018, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the patient experienced respiratory insufficiency (serious criteria hospitalization and GSK medically significant), meningoencephalitis (serious criteria hospitalization and GSK medically significant), vomiting (serious criteria hospitalization), stretch marks (serious criteria hospitalization), skin induration (serious criteria hospitalization), lethargy (serious criteria hospitalization), absent reflex (serious criteria hospitalization), stiffness (serious criteria hospitalization) and aggression (serious criteria hospitalization). The patient was treated with diazepam. The action taken with Dipirone was unknown. The action taken with ibuprofen was unknown. On an unknown date, the outcome of the death was fatal and the outcome of the respiratory insufficiency, meningoencephalitis, cerebral edema, febrile convulsion, diarrhea, fever, chills, self hatred, vomiting, mucus stools, stretch marks, skin induration, lethargy, absent reflex, soft stools, stiffness and aggression were unknown. It was unknown if the reporter considered the death, respiratory insufficiency, meningoencephalitis, cerebral edema, febrile convulsion, diarrhea, fever, chills, self hatred, vomiting, mucus stools, stretch marks, skin induration, lethargy, absent reflex, soft stools, stiffness and aggression to be related to Menjugate Liquid. It was unknown if the reporter considered the death, respiratory insufficiency, meningoencephalitis, cerebral edema, febrile convulsion, fever, chills, self hatred, vomiting, mucus stools, stretch marks, skin induration, lethargy, absent reflex, stiffness and aggression to be related to Influenza vaccine Quadrivalent 2018-2019 season, Dipirone and ibuprofen. Additional details were provided as follows: The patient was on breastfeeding. The patient medical history was born with a little more than 3,5 kg, born via vaginal labor, foot test performed and the little ear without alterations. The patient''s parent reported that the same was healthy and never needed hospitalization, attended all the appointments of puericulture, on the last appointment of April 2018 was weighting 10,400 kg and never had a seizure. The hygiene-sanitary conditions of the house were unsatisfactory, On 13th April 2018, the patient received Menjugate Liquid and Triple viral vaccine. On 4th May 2018, the patient received 1st dose of Influenza in the health center but without vaccinal comprovation. There were some divergencies of some start dates of symptoms between what was in the file and the mother reported during home visit. Research bias noted the patient''s mother emotional state prenatal care card lost, non-disponibility of child vaccination card. The patient was in complementary breastfeeding, parent reported that on days 3rd May 2018, and 4th May 2018, the patient presented diarrhea episodes with 5 daily evacuations with softened stools without blood and or mucus (Regular intestinal pattern of 1 evacuation / day) and had improvement of the clinical condition spontaneously without medical evaluation. On 3rd May 2018, the patient experienced diarrhea and softened stools. On 8th May 2018, the patient presented non-measured fever, parent administered by her own 10 drops of Ibuprofen. At night the patient presented chills, stayed hitting her/himself had 40 degree C fever and seizure. On 9th May the patient was hospitalized. The patient was taken to the emergency care unit and medicated with Dipirone, presented vomit and new episode of seizure crisis with evacuation of stools with mucus, being medicated with Diazepam according to the parent. The patient was intubated in the emergency care unit and transferred to HUT. On 25th May 2018, realized a possible AEPV. The patient evolved to death in 21st May 2018. On 19th June 2018, Cerebrospinal fluid was not collected because CT appointed diffuse cerebral edema. Less than 2 month after recevieng Menjugate and Influenza vaccine, less than 2 week after recevieng TRIPLE VIRAL vaccine and Ibuprofen, the patient followed without fever and stayed stretching, writhing, hitting her/himself and with hard foot. Chikungunya IGM serum non reactive, Epstein Barr IGM serum not reactive; Zika IGM serum not reactive. Quick IGM IGG dengue test not reactive; Zika IGG serum not reactive; Epstein Barr IGG not reactive; Chikungunya IGG serum not reactive, Cytomegalovirus IGM serum not reactive; Cytomegalovirus IGG not reactive (48,2); Zika PCR urine not detectable; Zika PCR Serum not detectable; Dengue PCR serum not dectable was performed a home visit to investigate the death. This case lacks a deepening in the investigation to be performed afterwards. Lab Comments: Zika IGM serum (not reactive), Zika PCR urine (not detectable)


VAERS ID: 869903 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-02-13
Onset:2020-04-03
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2020-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS T74L4 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Guillain-Barre syndrome, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), 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 (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-04-12
   Days after onset: 9
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: DEGLAXOSMITHKLINEDE202007

Write-up: Guillain-Barre syndrome; Respiratory insufficiency; This case was reported by a physician via regulatory authority and described the occurrence of guillain-barre syndrome in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number T74L4, expiry date unknown) for prophylaxis. Previously administered products included Shingrix (received on 6th November 2019). On 13th February 2020, the patient received Shingrix (unknown). On 3rd April 2020, 50 days after receiving Shingrix, the patient experienced guillain-barre syndrome (serious criteria death, hospitalization and GSK medically significant). On 12th April 2020, the patient experienced respiratory insufficiency (serious criteria death and GSK medically significant). On 12th April 2020, the outcome of the guillain-barre syndrome and respiratory insufficiency were fatal. The patient died on 12th April 2020. The reported cause of death was respiratory insufficiency and guillain-barre syndrome. An autopsy was not performed. It was unknown if the reporter considered the guillain-barre syndrome and respiratory insufficiency to be related to Shingrix. Additional information: The age at vaccination was not reported, but the patient could be 76 or 77 years old at the time of vaccination. The patient received Shingrix in left deltoid. The reported time to event onset for the event of guillain-barre syndrome was 51 days. However as per reported vaccination date and event onset date it was captured as 50 days. The Agency assessment for the event of guillain-barre syndrome was reported as unclassifiable or unknown. The event of guillain-barre syndrome was also captured as cause of death as the outcome of the event was reported as fatal and respiratory insufficiency was also captured as an event as it was after receiving the suspect vaccine and also the onset date was captured as death date because the event of respiratory insufficiency is a sudden event because of which the patient died. Initial information was reported by physician via regulatory authority on 1st May 2020: Guillain-barre syndrome.; Reported Cause(s) of Death: Respiratory insufficiency; Guillain-Barre syndrome


VAERS ID: 870625 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AR0095075132005ARG004357

Write-up: even death; secondary effects; This spontaneous report was received from an unspecified reporter, via Agency, referring to an unspecified number of patients of unknown age and gender. The information was found a comment at the fan webpage on social media. The patients'' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacturer unknown) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported). The reporter stated that "the secondary effects (adverse event) on this one and other vaccines were terrible, even death". It was unknown if an autopsy was performed. The cause of death was not reported. At the time of reporting, the outcome of adverse event was unknown. The causality assessment between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacturer unknown) was not provided. This is a non-valid case as no patient''s identifiers were provided.


VAERS ID: 870828 (history)  
Form: Version 2.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Congenital lung malformation NOS; Heart disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075132005CHN002239

Write-up: boy dies after being given MMR vaccine/ two year old who had pre-existing lung condition died in hospital a day after being given jab; lost consciousness; This spontaneous report was published in an online newspaper article by a consumer regarding a 2-year-old male child patient. The patient was previously vaccinated for hepatitis B, tuberculosis, polio, Hansen''s disease and also had a diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (DPT) jab. The patient''s concurrent conditions included a rare congenital lung malfunction called horseshoe lung which is associated with other heart and lung diseases. However, the health check before he was inoculated showed no abnormalities. The patient''s concomitant medications were not reported. On an unknown date, the patient was vaccinated with the shot of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (strength, dose, batch/lot# and expiry date were not reported) for prophylaxis. On an unknown date (reported as the following night), the patient lost consciousness and was rushed to hospital but the doctors were unable to revive the boy. The cause of death was not reported. It was unknown if autopsy was performed. The outcome of loss of consciousness was unknown. The causality assessment was not provided. Upon internal review, the event loss of consciousness was determined to be medically significant.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 871227 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2020-05-11
Onset:2020-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Infantile spasms
SMQs:, Convulsions (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-05-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNPFIZER INC2020194900

Write-up: infantile spasms; This is a spontaneous report from a contactable consumer (family member) reported for the family member via hotline. A 2-month-old male patient received first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, lot/batch and expiry date unknown) via an unspecified route of administration on 11May2020 at around 2 pm at single dose for immunization. The patient medical history and concomitant medications were not reported. The baby didn''t look abnormal before the injection. The patient was given the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) when he was 81-day-old in the centers for disease control and prevention at around 2 pm on 11May2020, then 4 hours after the vaccination, the patient experienced infantile spasms. After being rescued in the hospital, he died at about 2 am on 12May2020 after vaccination. The outcome of event infantile spasms was fatal. The patient died on 12May2020 at about 2 am. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: the patient experienced infantile spasms. After being rescued in the hospital, he died at about 2 am on 12May2020 after vaccination.


VAERS ID: 871626 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-10-30
Onset:2020-03-25
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-28
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003587

Write-up: Pneumonia from COVID-19; This is a spontaneous case, reported by pharmacist to Regulatory Authority (regulatory reference number: ES-AEMPS-630523) and initially retrieved on 21-May-2020, concerning a 84-year-old, female patient. The patient''s medical history and concomitant medications were not reported. On 30-Oct-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; batch number: 9153B1A; dose: 0.5 ml; route of administration: intramuscular; anatomical location and expiry date: not reported] as flu vaccination. On 25-Mar-2020, four months and 25 days after vaccination, the patient developed pneumonia from COVID-19. On 28-Apr-2020, the patient died due to the pneumonia from COVID-19. It was unknown if the autopsy was done. The event of ''COVID-19 pneumonia'' was considered serious due to the criterion of medical significance and fatal outcome. The reporter did not provide causality assessment. This case is linked with the cases: 202003580, 202003581, 202003582, 202003583, 202003584, 202003585 and 202003586 (Regulatory Authority link). Company comment: A 84-year-old, female patient experienced COVID-19 pneumonia, four months and 25 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to pneumonia from COVID-19. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 84-year-old, female patient experienced COVID-19 pneumonia, four months and 25 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to pneumonia from COVID-19. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630999: ES-AEMPS-630975: ES-AEMPS-630996: ES-AEMPS-630974: ES-AEMPS-630545: ES-AEMPS-630989: ES-AEMPS-630547:; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 871627 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-07
Onset:2020-04-14
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-04-26
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003586

Write-up: Pneumonia from COVID-19; This is a spontaneous case, reported by pharmacist to Regulatory authority (reference number: ES-AEMPS-630545) and initially retrieved on 21-May-2020, concerning a 75-year-old, male patient. The patient''s medical history and concomitant medications were not reported. On 07-Nov-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; batch number: 9153B1A; dose: 0.5 ml; route of administration: intramuscular; anatomical location and expiry date: not reported] as flu vaccination. On 14-Apr-2020, five months and seven days after vaccination, the patient developed pneumonia from COVID-19. On 26-Apr-2020, the patient died due to pneumonia from COVID-19. It was unknown if autopsy was performed. The event of COVID-19 pneumonia was considered serious due to the criterion of medical significance and fatal outcome. The reporter did not provide causality assessment to Chiromas (TIV). The case is linked to case 202003587 (regulatory authority link). Company comment: A 75-year-old, male patient experienced COVID-19 pneumonia, five months and seven days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to pneumonia from COVID-19. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 75-year-old, male patient experienced COVID-19 pneumonia, five months and seven days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to pneumonia from COVID-19. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630523: ES-SEQIRUS-202003587:Regulatory authority link; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 871628 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-04
Onset:2020-03-22
   Days after vaccination:139
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-25
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003580

Write-up: COVID-19 pneumonia; This is a spontaneous case, reported by a pharmacist to Regulatory Authority (regulatory reference number: ES-AEMPS-630547) and initially retrieved on 21-May-2020, concerning an 82-year-old, male patient. The patient''s medical history and concomitant medications were not provided. On 04-Nov-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, batch number: 9153B1A, anatomical location and expiry date: not reported] for flu vaccination. On 22-Mar-2020, 4 months 18 days after vaccination, the patient developed pneumonia from COVID-19. On 25-Mar-2020, the patient died from pneumonia from COVID-19 which was reported as cause of death. It was unknown if autopsy was performed. The event of ?COVID-19 pneumonia'' was considered serious due to criteria of death and medical significance. The reporter did not provide a causality assessment to Chiromas (TIV). This case is linked to case 202003587 (Regulatory Authority link). Company comment: A 82-year-old, male patient experienced COVID-19 pneumonia, 4 months 18 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 82-year-old, male patient experienced COVID-19 pneumonia, 4 months 18 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630523: ES-SEQIRUS-202003587:Regulatory authority link; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 871629 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-05
Onset:2020-03-25
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003583

Write-up: Suspected COVID-19; This is a spontaneous case reported by pharmacist to Regulatory authority (reference number: ES-AEMPS-630974) and initially retrieved on 21-May-2020, concerning a 76-year-old, female patient. The patient''s medical history and concomitant medications were not reported. On 05-Nov-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; batch number: 9153B1A; dose: 0.5 ml; route of administration: intramuscular; anatomical location and expiry date: not reported] as flu vaccination. On 25-Mar-2020, four months and twenty days after vaccination the patient developed suspected COVID-19 and died. Cause of death was reported as suspected COVID-19. It was unknown if autopsy was done. The event of ''suspected COVID-19'' was considered serious due to the criterion of fatal outcome. The reporter did not provide causality assessment to Chiromas (TIV). The case is linked to 202003587 (regulatory authority link). Company comment: A 76-year-old, female patient experienced suspected COVID-19 pneumonia, four months and twenty days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to suspected COVID-19 pneumonia. It was unknown if autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 76-year-old, female patient experienced suspected COVID-19 pneumonia, four months and twenty days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to suspected COVID-19 pneumonia. It was unknown if autopsy was performed. The patient''s medical history and concomitant medications were not reported. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630523: ES-SEQIRUS-202003587:Regulatory authority link; Reported Cause(s) of Death: Suspected COVID-19


VAERS ID: 871630 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-08
Onset:2020-04-29
   Days after vaccination:173
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-05-06
   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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003581

Write-up: Pneumonia from COVID-19; This is a spontaneous case, reported by pharmacist to Regulatory Authority (regulatory reference number: ES-AEMPS-630975) and initially retrieved on 21-May-2020, concerning an 89-year-old, male patient. The patient''s medical history and concomitant medications were not reported. On 08-Nov-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; batch number: 9153B1A; dose: 0.5 ml; route of administration: intramuscular; anatomical location and expiry date: not reported] as flu vaccination. On 29-Apr-2020, five months and 21 days after vaccination, the patient developed pneumonia from COVID-19. On 06-May-2020, the patient died due to the pneumonia from COVID-19. It was unknown if the autopsy was done. The event of ''COVID-19 pneumonia'' was considered serious due to the criterion of medical significance and fatal outcome. The reporter did not provide causality assessment. This case is linked with the case 202003587 (Regulatory Authority link). Company comment: A 89-year-old, male patient experienced COVID-19 pneumonia, five months and 21 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 89-year-old, male patient experienced COVID-19 pneumonia, five months and 21 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630523:; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 871631 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-04
Onset:2020-03-20
   Days after vaccination:137
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-24
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003582

Write-up: Pneumonia from COVID-19; This is a spontaneous case, reported by a pharmacist to regulatory authority (regulatory reference number: ES-AEMPS-630989) and initially retrieved on 21-May-2020, concerning a 73-year-old, male patient. The patient''s relevant medical history and concomitant medications were not reported. On 04-Nov-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular, batch number: 9153B1A, anatomical location and expiration date: not reported] for flu vaccination. On 20-Mar-2020, the patient developed pneumonia due to coronavirus infection COVID-19. On 24-Mar-2020, the patient died due to COVID-19 pneumonia. It was unknown whether autopsy was performed. The event of COVID-19 pneumonia was considered as serious due to seriousness criteria of death and medical significance (per company). The reporter did not provide causality assessment to Chiromas (TIV). This case is linked to case 202003587 as regulatory authority link. Company comment: A 73-year-old, male patient experienced COVID-19 pneumonia, 4 months 16 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia. It was unknown whether an autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 73-year-old, male patient experienced COVID-19 pneumonia, 4 months 16 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to COVID-19 pneumonia. It was unknown whether an autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630523: ES-SEQIRUS-202003587:Regulatory authority link; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 871632 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2019-12-04
Onset:2020-03-26
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-03-30
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003585

Write-up: Pneumonia from COVID-19; This is a spontaneous case, reported by a pharmacist to regulatory authority (regulatory reference number: ES-AEMPS-630996) and initially retrieved on 21-May-2020, concerning an 84-year-old, female patient. The patient''s medical history and concomitant medications were not provided. On 04-Dec-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, batch number: 9153B1A, anatomical location and expiry date: not reported] for flu vaccination. On 26-Mar-2020, 3 months 22 days after vaccination, the patient developed pneumonia from COVID-19. On 30-Mar-2020, the patient died and pneumonia from COVID-19 was reported as cause of death. It was unknown if autopsy was performed. The event of ?COVID-19 pneumonia'' was considered serious due to criteria of death and medical significance. The reporter did not provide a causality assessment to Chiromas (TIV). This case is linked to case 202003587 (Regulatory Authority link). Company comment: A 84-year-old, female patient experienced COVID-19 pneumonia, 3 months 22 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to pneumonia from COVID-19. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 84-year-old, female patient experienced COVID-19 pneumonia, 3 months 22 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, the patient died due to pneumonia from COVID-19. It was unknown if autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630523: ES-SEQIRUS-202003587:Regulatory authority link; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 871633 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-14
Onset:2020-03-26
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2020-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (CHIROMAS) / NOVARTIS VACCINES AND DIAGNOSTICS 9153B1A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Death
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-05-09
   Days after onset: 44
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESSEQIRUS202003584

Write-up: Pneumonia from COVID-19; This is a spontaneous case, reported by pharmacist to regulatory authority (regulatory reference number: ES-AEMPS-630999) and initially retrieved on 21-May-2020, concerning a 73-year-old, male patient. The patient''s medical history and concomitant medications were not reported. On 14-Nov-2019, the patient was administered Chiromas (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular, batch number: 9153B1A, anatomical location and expiry date: not reported] as flu vaccination. On 26-Mar-2020, four months and 12 days after vaccination, the patient developed pneumonia from COVID-19. On 09-May-2020, 45 days after the onset, the patient died. The cause of death was reported as pneumonia from COVID-19. It was unknown whether autopsy was performed. The event of COVID-19 pneumonia was assessed as serious due to the criterion of medical significance and fatal outcome. The reporter did not provide causality assessment to Chiromas (TIV). This case is linked to case 202003587 (regulatory authority link). Company comment: A 73-year-old, male patient experienced COVID-19 pneumonia, 4 months 12 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, 45 days after the onset, the patient died. The cause of death was reported as pneumonia from COVID-19. It was unknown whether autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine.; Sender''s Comments: A 73-year-old, male patient experienced COVID-19 pneumonia, 4 months 12 days after administration of Chiromas (TIV) influenza vaccine. Reportedly, 45 days after the onset, the patient died. The cause of death was reported as pneumonia from COVID-19. It was unknown whether autopsy was performed. Considering infectious aetiology of the event and biological implausibility, the causality is assessed as not related to the suspect vaccine. ES-AEMPS-630523: ES-SEQIRUS-202003587:Regulatory authority link; Reported Cause(s) of Death: Pneumonia from COVID-19


VAERS ID: 872483 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2020-05-18
Onset:2020-05-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2020-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER R3C335V / 1 RL / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH DA8219 / UNK LL / OT
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-05-23
   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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075132006DEU000272

Write-up: Death infant sudden; Information has been downloaded from regulatory authority (DE-PEI-PEI2020002711). This spontaneous report was received from a physician concerning a 3-month-old male patient. The patient''s historical drug included rotavirus vaccine, live, oral, pentavalent (ROTATEQ); his concurrent conditions, concomitant therapies, and allergies were not reported. On 18-MAY-2020, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) by oral route, lot #3038661, (strength, anatomical site of injection, and expiration date were not reported), pneumococcal 13v conj vaccine (crm197) (PREVENAR 13), by intramuscular route, on the left thigh, lot #DA8219, and with the first dose of hib conj vaccine (tet toxoid), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 2-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (HEXYON), by intramuscular route, right thigh, lot #R3C335V (strengths, formulations and expiration date were not reported), all vaccines were given as prophylaxis. On 23-MAY-2020, the patient experienced sudden infant death syndrome, therefore, the cause of death was reported as sudden death syndrome as well. The causality assessment between all the suspect vaccines and the patient''s death was reported as unclassifiable (unknown). "Lot number 3038661 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent".; Reported Cause(s) of Death: Death infant sudden


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